Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- FLKThermometer, Clinical Mercury2Product Code
- CARMonitor, Spinal-Fluid Pressure, Electrically Powered2Product Code
- FLLThermometer, Electronic, Clinical2Product Code
- K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)2Cleared 510(K)
- K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)2Cleared 510(K)
- K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)2Cleared 510(K)
- K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)2Cleared 510(K)
- K243082Infrared Thermometer2Cleared 510(K)
- K250401AION TempShield™2Cleared 510(K)
- K243136Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)2Cleared 510(K)
- K240333Wearable Digital Thermometer (T31)2Cleared 510(K)
- K240223FMT Disposable and Autoclavable Temperature Probes2Cleared 510(K)
- K240220Aulisa Temperature Module (TM0002)2Cleared 510(K)
- K240077Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)2Cleared 510(K)
- K233280SteadyTemp2Cleared 510(K)
- K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)2Cleared 510(K)
- K240109Medical electronic thermometer (FC01, FC02)2Cleared 510(K)
- K233192Wireless Smart Thermometer2Cleared 510(K)
- K230889Digital Thermometer2Cleared 510(K)
- K240023Probe Covers (YF-001, YF-002)2Cleared 510(K)
- K232473Infrared Thermometer: Model YJ6002Cleared 510(K)
- K231625VitalDetect2Cleared 510(K)
- K232678Digital Thermometer, Model T28, T28L2Cleared 510(K)
- K232338Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F3832Cleared 510(K)
- K222057THERMOCLICK2Cleared 510(K)
- K232128Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)2Cleared 510(K)
- K223807Reusable Temperature Probe, Disposable Temperature Probe2Cleared 510(K)
- K230298Celsi Monitor2Cleared 510(K)
- K232010iTEMPSHIELD2Cleared 510(K)
- K223037Infrared Thermometer, Model: IR88072Cleared 510(K)
- K213100FMT Reusable Temperature Probes2Cleared 510(K)
- K210924e-Celsius Medical System2Cleared 510(K)
- K223522NC° Thermometer (Gen 3), Model Number: NCTG32Cleared 510(K)
- K222248Infrared Thermometer2Cleared 510(K)
- K222311CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System2Cleared 510(K)
- K223044Digital Thermometer (Model QT001)2Cleared 510(K)
- K222588Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-12Cleared 510(K)
- K220276Infrared Thermometer TET-3512Cleared 510(K)
- K220657Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)2Cleared 510(K)
- K214077Digital Thermometer, Model: DT007, DT0082Cleared 510(K)
- K221039Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y2Cleared 510(K)
- K221800Infrared Thermometer (Model: Y20001, Y20002)2Cleared 510(K)
- K211050Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-3042Cleared 510(K)
- K221170Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F1072Cleared 510(K)
- K221211Infrared thermometer2Cleared 510(K)
- K220084Infrared Forehead Thermometer2Cleared 510(K)
- K213485Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E2Cleared 510(K)
- K210937Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F2412Cleared 510(K)
- K212346Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT16182Cleared 510(K)
- K210565Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R7112Cleared 510(K)
- K212257Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E3112Cleared 510(K)
- K213746Digital thermometer, Model DT101, DT1022Cleared 510(K)
- K213011Infrared Thermometer (model: E201)2Cleared 510(K)
- K200946Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)2Cleared 510(K)
- K210171Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)2Cleared 510(K)
- K213038Infrared Forehead Thermometer, model: HS-9802D2Cleared 510(K)
- K212945Sterile Disposable Temperature Probe2Cleared 510(K)
- K211776Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)2Cleared 510(K)
- K213084Ear Thermometer, Model ET005, ET008, ET0092Cleared 510(K)
- K213079Ear Thermometer, Model ET0012Cleared 510(K)
- K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-3112Cleared 510(K)
- K212598iHealth infrared Ear thermometer PT52Cleared 510(K)
- K211752Infrared Thermometer2Cleared 510(K)
- K210564Infrared Thermometer2Cleared 510(K)
- K200943Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System2Cleared 510(K)
- K201600Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-282Cleared 510(K)
- K211629Infrared forehead thermometer LD-FT-100B2Cleared 510(K)
- K211744Non-Contact Infrared Thermometer, model HL710H2Cleared 510(K)
- K201032Phoenix Digital Thermometer2Cleared 510(K)
- K203497Infrared Thermometer (Model K9)2Cleared 510(K)
- K202481ThermArt (Model IR-EFT)2Cleared 510(K)
- K203731DT100 Digital Thermometer2Cleared 510(K)
- K203662Infrared thermometer, Models: YRK-002A, T8, T9, T10, T112Cleared 510(K)
- K211931Medline Digital Thermometer Non-Lubricated Probe Sheath2Cleared 510(K)
- K210118INFRARED BODY THERMOMETER (Model: YK-001)2Cleared 510(K)
- K211352Electronic Thermometer (XHF2001, XHF2002)2Cleared 510(K)
- K211583Infrared Thermometer, Model: HW-12Cleared 510(K)
- K203636PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG2Cleared 510(K)
- K203643Sensatronic Reusable Temperature Probes2Cleared 510(K)
- K203431Disposable Ear Thermometer Probe Cover2Cleared 510(K)
- K202296Infrared Forehead Thermometer, Model BSX9762Cleared 510(K)
- K202603Temp Pal2Cleared 510(K)
- K202741Infrared Forehead Thermometer2Cleared 510(K)
- K202440Infrared Thermometer2Cleared 510(K)
- K203215Radius T wearable thermometer2Cleared 510(K)
- K210014Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)2Cleared 510(K)
- K203583YUWELL infrared ear thermometer: YHT101, YHT2002Cleared 510(K)
- K203454Infrared Thermometer2Cleared 510(K)
- K203170Infrared Thermometer Models: DT-8806S, DT-8807S2Cleared 510(K)
- K201879Digital Thermometer Model T103, T1042Cleared 510(K)
- K202009Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-0262Cleared 510(K)
- K203707Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-6032Cleared 510(K)
- K202591Body Infrared Thermometer HT-820D2Cleared 510(K)
- K201508Infrared Thermometer2Cleared 510(K)
- K202753iHealth Wireless No-Touch Forehead Thermometer2Cleared 510(K)
- K202111Medical infrared forehead thermometer2Cleared 510(K)
- K203332Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C2Cleared 510(K)
- K202420Infrared Forehead Thermometer2Cleared 510(K)
- K202687Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR602Cleared 510(K)
- K202368Infrared Thermometer2Cleared 510(K)
- K201536Infrared Forehead Thermometer2Cleared 510(K)
- K203747Non-Contact Forehead Thermometer (Models UT306H & UT308H)2Cleared 510(K)
- K203656Non-Contact Forehead Thermometer (UT30H)2Cleared 510(K)
- K201582Non-contact Electronic Forehead Infrared Thermometer2Cleared 510(K)
- K201579Infrared Thermometer2Cleared 510(K)
- K202791iHealth Clinical Digital Thermometer2Cleared 510(K)
- K200159Non-contact Infrared Body Thermometer, model:HTD8823US2Cleared 510(K)
- K200631DeRoyal Temperature Monitoring Probe2Cleared 510(K)
- K201980Infrared Thermometer2Cleared 510(K)
- K191978Fever Garde2Cleared 510(K)
- K200781Infrared Body Thermometer2Cleared 510(K)
- K201864YUWELL Infrared Thermometer2Cleared 510(K)
- K201977TempTraq2Cleared 510(K)
- K193621Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)2Cleared 510(K)
- K201843Infrared ear and forehead thermometer, model YI-1002Cleared 510(K)
- K200802Infrared Thermometer2Cleared 510(K)
- K201161Infrared Thermometer Model E1272Cleared 510(K)
- K200710Infrared PT2L Digital No-Touch Thermometer2Cleared 510(K)
- K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes2Cleared 510(K)
- K193625Disposable Temperature Probe2Cleared 510(K)
- K200578Infrared Thermometer Model Number RN-50A,RN-50B2Cleared 510(K)
- K200531iHealth Infrared No-Touch Forehead Thermometer2Cleared 510(K)
- K200599Digital Thermometer2Cleared 510(K)
- K200471Infrared Thermometer Model Number RN-60A,RN-60B2Cleared 510(K)
- K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T15032Cleared 510(K)
- K193213Vicks VNT200 No Touch Forehead Thermometer2Cleared 510(K)
- K190984Infrared Forehead Thermometer2Cleared 510(K)
- K191829Microlife Non-Contact Infrared Forehead Thermometer2Cleared 510(K)
- K190990Digital Thermometer2Cleared 510(K)
- K190717Infrared Thermometer, model: PC8082Cleared 510(K)
- K183393Digital Thermometer2Cleared 510(K)
- K191570Infrared Thermometer Model MD-H302Cleared 510(K)
- K191668Infrared Forehead Thermometer (Model IR-FT)2Cleared 510(K)
- K191283Infrared Thermometer, Breeze model2Cleared 510(K)
- K191251Infared Thermometer2Cleared 510(K)
- K192210ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System2Cleared 510(K)
- K182751Reusable Temperature Probe2Cleared 510(K)
- K191004Advocate Non-Contact Infrared Thermometer2Cleared 510(K)
- K190873Infrared Ear/Forehead Thermometer2Cleared 510(K)
- K183663Microlife Digital Infrared Ear Thermometer2Cleared 510(K)
- K182667Med-link Temperature Probes2Cleared 510(K)
- K183431Medline Digital Rectal Thermometer Sheath2Cleared 510(K)
- K182437Wireless Intelligent Thermometer2Cleared 510(K)
- K182597Infrared thermometer2Cleared 510(K)
- K190242Tyto Thermometer2Cleared 510(K)
- K182629Digital Thermometer2Cleared 510(K)
- K180767FEMON Banana Thermometer2Cleared 510(K)
- K180387Infrared Ear Thermometer2Cleared 510(K)
- K180355Advocate Non-Contact Infrared Thermometer2Cleared 510(K)
- K181215Infrared Thermometer2Cleared 510(K)
- K182755Disposable Temperature Probe2Cleared 510(K)
- K181967Disposable Temperature Probe2Cleared 510(K)
- K173048No-contact Forehead Thermometer2Cleared 510(K)
- K163601RII Smart IR Thermometer2Cleared 510(K)
- K180298welloStationX2Cleared 510(K)
- K180207Non-contact Infrared Thermometer2Cleared 510(K)
- K182652COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-102Cleared 510(K)
- K182133Infrared Thermometer2Cleared 510(K)
- K180047ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System2Cleared 510(K)
- K181239Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer2Cleared 510(K)
- K170723Swaive Thermometer SWT1A2Cleared 510(K)
- K172733TD-1035 Thermometer2Cleared 510(K)
- K173194Temperature Probe2Cleared 510(K)
- K181081Infrared Ear Thermometer2Cleared 510(K)
- K180714Probe Covers for Thermometers2Cleared 510(K)
- K181013Fever Scout2Cleared 510(K)
- K180131Vicks RapidRead Digital Thermometer2Cleared 510(K)
- K172508Ageless Health Medical Digital Thermometer2Cleared 510(K)
- K181242Braun BNT400 No Touch + Forehead Thermometer2Cleared 510(K)
- K171888Non-contact infrared body thermometer2Cleared 510(K)
- K181015Braun BFH175 Infrared Forehead Thermometer2Cleared 510(K)
- K172874Infrared Thermometer2Cleared 510(K)
- K180314Infrared Thermometer2Cleared 510(K)
- K172121Digital Thermometer2Cleared 510(K)
- K172889Infrared Thermometer2Cleared 510(K)
- K172894Infrared Thermometer2Cleared 510(K)
- K180385Infrared Body Thermometer2Cleared 510(K)
- K172427AViTA Radar Thermo NT16 Series IR Thermometer2Cleared 510(K)
- K180148ATS Thermal Imaging Probe, ATS Patient Interface Unit2Cleared 510(K)
- K172795Infrared Thermometer2Cleared 510(K)
- K171214Infrared Thermometer2Cleared 510(K)
- K172870Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J2Cleared 510(K)
- K171455AT-6XX Series Infrared Thermometer2Cleared 510(K)
- K173730Kinsa QuickCare Thermometer2Cleared 510(K)
- K173113Medline Disposable Electronic Thermometer Probe Cover2Cleared 510(K)
- K172861Digital thermometer(with disposable thermometer cover)2Cleared 510(K)
- K171578Infrared thermometer2Cleared 510(K)
- K170662Non Contact Infrared Forehead Thermometer2Cleared 510(K)
- K171182ri-former Predictive Thermometer2Cleared 510(K)
- K170262Digital Thermometer2Cleared 510(K)
- K163518Digital Thermometer2Cleared 510(K)
- K170769wireless thermometer2Cleared 510(K)
- K170219Microlife Digital Infrared Ear Thermometer2Cleared 510(K)
- K163603Digital Thermometer2Cleared 510(K)
- K163516Braun No Touch + Forehead NTF3000 Thermometer2Cleared 510(K)
- K160680VisioFocus Mini, VisioFocus Smart2Cleared 510(K)
- K163256Dual Mode Infrared Thermometer2Cleared 510(K)
- K162509Infrared Non-contact Thermometer, Model ACT81002Cleared 510(K)
- K160358DT-1002Cleared 510(K)
- K162137Fever Scout™ Continuous Monitoring thermometer2Cleared 510(K)
- K162083RII Multi-function Infrared Thermometer, Model TH52Z2Cleared 510(K)
- K160306Cloud Smart Thermometer2Cleared 510(K)
- K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-12Cleared 510(K)
- K161735Non-contact Forehead Thermometer2Cleared 510(K)
- K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)2Cleared 510(K)
- K161211Digital Thermometer2Cleared 510(K)
- K160802Infrared Forehead Thermometer, FT-100A2Cleared 510(K)
- K161933The Braun ThermoScan® 3 High Speed Compact Ear Thermometer2Cleared 510(K)
- K160999Infra-red forehead thermometer2Cleared 510(K)
- K152905ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer2Cleared 510(K)
- K160308Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)2Cleared 510(K)
- K161325CliniCloud Non-contact Thermometer, Model SPL10242Cleared 510(K)
- K160544Withings Thermo (Model SCT01)2Cleared 510(K)
- K153149Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-362Cleared 510(K)
- K160091Temperature Probe, Affinity Temperature Probe2Cleared 510(K)
- K152680TD-1035 Thermometer2Cleared 510(K)
- K153146Infrared Ear Thermometer2Cleared 510(K)
- K152640Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)2Cleared 510(K)
- K152975VDT985US Vicks SmartTemp Thermometer2Cleared 510(K)
- K152402IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)2Cleared 510(K)
- K152748Braun Thermoscan PRO 6000 Ear Thermometer2Cleared 510(K)
- K152739Electronic Thermometer2Cleared 510(K)
- K152690DISPOSABLE THERMOMETER PROBE SHEATHS2Cleared 510(K)
- K152508Ageless Health Medical Digital Thermometer2Cleared 510(K)
- K150160Temple Touch Pro (TTP) Non-invasive temperature monitoring system2Cleared 510(K)
- K143267TempTraq TT-1002Cleared 510(K)
- K141505BASAL DIGITAL THERMOMETER2Cleared 510(K)
- K140681BELTER INFRA-RED EAR THERMOMETER2Cleared 510(K)
- K132761WIRELESS THERMOMETER2Cleared 510(K)
- K134043NO TOUCH+FOREHEAD NTF 3000 THERMOMETER2Cleared 510(K)
- K131210ELECTRONIC THERMOMETER2Cleared 510(K)
- K132457FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER2Cleared 510(K)
- K132140DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER2Cleared 510(K)
- K133113KINGTECH FOREHEAD THERMOMETER2Cleared 510(K)
- K133111KINGTECH DIGITAL THERMOMETER2Cleared 510(K)
- K132514KINSA SMART THERMOMETER2Cleared 510(K)
- K131243NON-CONTACT INFRARED THERMOMETER2Cleared 510(K)
- K130231NON-CONTACT INFRARED THERMOMETER2Cleared 510(K)
- K131771CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES2Cleared 510(K)
- K131155UGFT3; FHT72Cleared 510(K)
- K120671DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)2Cleared 510(K)
- K130361THERMOFINDER; THERMOCARE2Cleared 510(K)
- K122221NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER2Cleared 510(K)
- K122412VISIOFOCUS2Cleared 510(K)
- K121999GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE2Cleared 510(K)
- K123361ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM2Cleared 510(K)
- K122520DIGITAL THERMOMTER2Cleared 510(K)
- K120711NON-CONTACT THERMOMETER2Cleared 510(K)
- K122912DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)2Cleared 510(K)
- K121696WIRELESS THERMOMETER2Cleared 510(K)
- K113761INFRARED THERMOMETER2Cleared 510(K)
- K120004(MULTIPLE) DIGITAL THERMOMETER2Cleared 510(K)
- K121428NON-CONTACT CLINICAL THERMOMETER2Cleared 510(K)
- K121118FORA COMFORTSCAN EAR THERMOMETER2Cleared 510(K)
- K120712FORA COMFORTSCAN EAR THERMOMETER2Cleared 510(K)
- K1204123M SPOTON TEMPERATURE MONITORING SYSTEM2Cleared 510(K)
- K121427UNIMED TEMPERATURE PROBE2Cleared 510(K)
- K111703INFRARED EAR THEROMETER2Cleared 510(K)
- K113095E-CARE INFRARED EAR THERMOMETER2Cleared 510(K)
- K111463VALEO VT-601 SERIES IR THERMOMETER2Cleared 510(K)
- K113141MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ12Cleared 510(K)
- K112189THERMO PAL INFRARED EAR THERMOMETER2Cleared 510(K)
- K113159U-RIGHT TD-1240 THERMOMETER2Cleared 510(K)
- K110559AVITA INFRARED THEROMETER WITH BLUETOOTH2Cleared 510(K)
- K112289DISPOSABLE THERMOMETER COVERS AND SHEATHS2Cleared 510(K)
- K111637INFRARED EAR THERMOMETER2Cleared 510(K)
- K112929THERMOFLASH(TM) INFRARED THERMOMETER2Cleared 510(K)
- K112703SHAKER DIGITAL THERMOMETER2Cleared 510(K)
- K112116DIGITAL CLINICAL THERMOMETER MODEL V901US2Cleared 510(K)
- K112376S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM2Cleared 510(K)
- K110776DIGITAL THERMOMETER MT SERIES2Cleared 510(K)
- K111974ION HEALTH USB INSTA-SCAN THERMOMETER2Cleared 510(K)
- K111282DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES2Cleared 510(K)
- K110956MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR2Cleared 510(K)
- K103839BEHIND EAR GENTLE TOUCH THERMOMETER2Cleared 510(K)
- K102935INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A2Cleared 510(K)
- K103407COTRONIC DIGITAL THERMOMETER2Cleared 510(K)
- K103680MICROLIFE DIGITAL UNDERARM THERMOMETER2Cleared 510(K)
- K103617DIGITAL FOREHEAD THERMOMETER2Cleared 510(K)
- K102554AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES2Cleared 510(K)
- K102947NON-CONTACT INFRARED THERMOMETER2Cleared 510(K)
- K103800BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS2Cleared 510(K)
- K102934INFRARED EAR THERMOMETER, MODEL IR-04MT2Cleared 510(K)
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- K070878DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-23002Cleared 510(K)
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- K062010RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES2Cleared 510(K)
- K062016RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES2Cleared 510(K)
- K061942TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M10242372Cleared 510(K)
- K061800CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER2Cleared 510(K)
- K061007GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS2Cleared 510(K)
- K060649GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 3030002Cleared 510(K)
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- K060173ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS2Cleared 510(K)
- K051699SEJOY, MODEL MT-4032Cleared 510(K)
- K060006BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER2Cleared 510(K)
- K051566PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER2Cleared 510(K)
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- K051873DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES2Cleared 510(K)
- K051269RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES2Cleared 510(K)
- K051251INFRARED EAR THEMOMETER, MODELS DX6603, DX663902Cleared 510(K)
- K051422DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE2Cleared 510(K)
- K050463CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER2Cleared 510(K)
- K051233OMRON MODEL 514N TYMPANIC THERMOMETER2Cleared 510(K)
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- K050837REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE2Cleared 510(K)
- K050137TEMPTOUCH DERMAL THERMOMETER2Cleared 510(K)
- K043331DIGITAL FOREHEAD THERMOMETER, MODEL FS-1002Cleared 510(K)
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- K050230TURBO TEMP TRIO2Cleared 510(K)
- K032434CLINICAL ELECTRONIC THERMOMETER2Cleared 510(K)
- K042631EAR THERMOMETER, MODEL WL-320X2Cleared 510(K)
- K043110MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L12Cleared 510(K)
- K042653PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP2Cleared 510(K)
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- K042627EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST652Cleared 510(K)
- K042575AMPLIFE DIGITAL CLINICAL THERMOMETER2Cleared 510(K)
- K040377RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES2Cleared 510(K)
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- K041694DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER2Cleared 510(K)
- K042202TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-5022Cleared 510(K)
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- K041516DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX92Cleared 510(K)
- K041646THERMOTEK Q52Cleared 510(K)
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- K033790THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES2Cleared 510(K)
- K04105610-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST882Cleared 510(K)
- K033077EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-0212Cleared 510(K)
- K033534VITALSENSE2Cleared 510(K)
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- K032612IR FOREHEAD THERMOMETER, MODEL HV-T362Cleared 510(K)
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- K033817MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-22Cleared 510(K)
- K033818MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU42902Cleared 510(K)
- K032362UP-GRADE FOREHEAD THERMOMETER2Cleared 510(K)
- K0330829 SECOND DIGITAL THERMOMETER, MODEL BT-S092Cleared 510(K)
- K033069DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-2052Cleared 510(K)
- K031928BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT)2Cleared 510(K)
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- K032714CARDICARE MODEL MT-301F & MT-301C2Cleared 510(K)
- K032364MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932)2Cleared 510(K)
- K032658MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER2Cleared 510(K)
- K031907NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 400, 401, 450, 451; ET 500, 501, 550, 5512Cleared 510(K)
- K031958MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA12Cleared 510(K)
- K030219DIGITAL TEMPERATURE MONITOR; MODEL KY-012Cleared 510(K)
- K031905DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 30302Cleared 510(K)
- K031556VIVATHERM THEMPERATURE MEASUREMENT SYSTEM2Cleared 510(K)
- K030580SURETEMP PLUS2Cleared 510(K)
- K023412THERMO BUDDY, MODELS TB-100, TB-110, TB-1202Cleared 510(K)
- K030673FLEXIBLE TIP THERMOMETER, MODEL 0112062Cleared 510(K)
- K030658STANDARD THERMOMETER2Cleared 510(K)
- K030324RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES2Cleared 510(K)
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- K030361JASUN, MODELS DT-01F AND DT-11F2Cleared 510(K)
- K030126NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN 600,610,620,630,602,612,622,632, TS 600,62Cleared 510(K)
- K023510TRUTEK SELECT MODEL TT-10012Cleared 510(K)
- K023500DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-33062Cleared 510(K)
- K023711DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE2Cleared 510(K)
- K023538TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER2Cleared 510(K)
- K023069TIMEX DIGITAL ORAL THERMOMETERS; TIMEX ACCUCURVE ORAL THERMOMETER2Cleared 510(K)
- K022542PHILIPS BABY THERMOMETER SET (SBC SC530)2Cleared 510(K)
- K021753E-CARE INFARED EAR THERMOMETER, MODEL LCT-2002Cleared 510(K)
- K020520EASYTEM EAR THERMOMETER, MODEL BT-0202Cleared 510(K)
- K012974PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 150072Cleared 510(K)
- K021851DIGITAL CLINICAL THERMOMETER, MODEL KD-1932Cleared 510(K)
- K020433FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER2Cleared 510(K)
- K021601MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER2Cleared 510(K)
- K021612DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 20382Cleared 510(K)
- K021614DIGITAL CLINICAL THERMOMETER, MODEL ACT 30202Cleared 510(K)
- K020471HIVOX EAR THERMOMETER, TS SERIES2Cleared 510(K)
- K021048THERMOMETER MODELS ST86312Cleared 510(K)
- K021052MODEL GT010706 ELECTRONIC THERMOMETER2Cleared 510(K)
- K021028MODEL GT980201 ELECTRONIC THERMOMETER2Cleared 510(K)
- K013779THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F2Cleared 510(K)
- K020725MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE12Cleared 510(K)
- K013876INFRARED EAR THERMOMETER, MODEL DX-7072Cleared 510(K)
- K020504INFRARED EAR THERMOMETER, MODELS TH88 SERIES2Cleared 510(K)
- K011059INFARED EAR THERMOMETER, MODEL TH8 SERIES2Cleared 510(K)
- K012136AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER2Cleared 510(K)
- K012217M5T INSTANT FEVER THERMOMETER2Cleared 510(K)
- K011291TEMPORALSCANNER THERMOMETER, SENSORTOUCH2Cleared 510(K)
- K011254EAR THERMOMETER, MODELS ST613C AND ST613F2Cleared 510(K)
- K010235TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX2Cleared 510(K)
- K011704NPAC EAR THERMOMETER MODEL TD 4022Cleared 510(K)
- K011585FAST THERMOMETER MODELS ST713C AND ST713F2Cleared 510(K)
- K002727YOUNG-HEALTH SUPER EAR THERMOMETER2Cleared 510(K)
- K001281GERATHERM BABYWATCH TEMPERATURE MONITOR2Cleared 510(K)
- K010866TEMP-A-SURE2Cleared 510(K)
- K010383TEMP SCAN2Cleared 510(K)
- K010462AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)2Cleared 510(K)
- K003326FUNET AMY MAMA BODY THERMOMETER2Cleared 510(K)
- K010224NPAC MULTI-USE THERMOMETER, MODEL TD4002Cleared 510(K)
- K010502MODEL THERMO TEK QUICKCARE2Cleared 510(K)
- K002712THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F2Cleared 510(K)
- K010238ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+2Cleared 510(K)
- K003223GEON DIGITAL CLINICAL THERMOMETER2Cleared 510(K)
- K003313FILAC FAS TEMP ELECTRONIC THERMOMETER2Cleared 510(K)
- K002182AVITA TSO/TS1 INFRARED EAR THERMOMETER2Cleared 510(K)
- K003308MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD12Cleared 510(K)
- K002562PACIFIER THERMOMETER MODELS VT-901F, VT901C2Cleared 510(K)
- K993950CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO99992Cleared 510(K)
- K000969MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA12Cleared 510(K)
- K001279GT990402 DIGITAL THERMOMETER2Cleared 510(K)
- K001008TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-9212Cleared 510(K)
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- K984551INFRARED EAR THERMOMETER, MODEL KI-81202Cleared 510(K)
- K992601TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-2032Cleared 510(K)
- K992468BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER2Cleared 510(K)
- K991914SUPER SOOTHER2Cleared 510(K)
- K992327DUTECK DIGITAL CLINICAL THERMOMETER2Cleared 510(K)
- K984506SD-100 SKYEAR THERMOMETER2Cleared 510(K)
- K984497TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-2012Cleared 510(K)
- K983576DR180-R/OXY2Cleared 510(K)
- K983295BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/35202Cleared 510(K)
- K983355SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR2Cleared 510(K)
- K990168MICROLIFE IT2CA12Cleared 510(K)
- K983887UP-GRADE AND UP-GRADE PRO2Cleared 510(K)
- K984553TALKING DIGITAL THERMOMETER, MODEL KV-1712Cleared 510(K)
- K982140CLINICAL ELECTRONIC THERMOMETER2Cleared 510(K)
- K983619BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER2Cleared 510(K)
- K983406SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR2Cleared 510(K)
- K981337DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A2Cleared 510(K)
- K981708DENTAL PORCELAIN-VARIOUS2Cleared 510(K)
- K981456BABY PACIFIER DIGITAL THERMOMETER2Cleared 510(K)
- K971831QUICK CHECK INSTANT THERMOMETER2Cleared 510(K)
- K971994B-D ASSURE EAR THERMOMETER2Cleared 510(K)
- K974195FLEXIBLE TIP DIGITAL THERMOMETER2Cleared 510(K)
- K972259PRO CHECK DIGITAL PACIFIER THERMOMETER2Cleared 510(K)
- K970011ESCORT II CLINICAL THERMOMETRY MODULE (CTM)2Cleared 510(K)
- K971866ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS610102Cleared 510(K)
- K964605BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000)2Cleared 510(K)
- K971045BASIS FLEXIBLE TIP DIGITAL THERMOMETER2Cleared 510(K)
- K970271ALEXANDER MANUFACTURING COMPANY2Cleared 510(K)
- K964851ENTRACARE THERMOMTER MODEL 10002Cleared 510(K)
- K964643SURETEMP2Cleared 510(K)
- K954523THERMOSCAN INSTANT THERMOMETER MODEL IR-60002Cleared 510(K)
- K963276THE SAFETY 1ST DIGITAL PACIFIER2Cleared 510(K)
- K964286ZOMED PASSIVE TEMPERATURE PROBE2Cleared 510(K)
- K952001GEON ELECTRONIC THERMOMETER2Cleared 510(K)
- K962497Q-TIPS, FAICHNEY, PRIVATE LABEL2Cleared 510(K)
- K955846MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER2Cleared 510(K)
- K962991BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER2Cleared 510(K)
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- K962386SENSOR SHEATH TS12Cleared 510(K)
- K962369TALKING DIGITAL THERMOMETER2Cleared 510(K)
- K961357PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE2Cleared 510(K)
- K961365ENDOCARE ELECTORNIC THERMOMETER SYSTEM2Cleared 510(K)
- K962070YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE2Cleared 510(K)
- K954792LUMISCOPE MODEL 2018 THERMOMETER2Cleared 510(K)
- K961879ELECTRONIC THERMOMETER2Cleared 510(K)
- K952541PACIFIER THERMOMETER2Cleared 510(K)
- K955142DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A2Cleared 510(K)
- K954434OLYMPIC INFANT THERMOMETER2Cleared 510(K)
- K952073PACI-TEMP, PACIFIER WITH DIGITAL THERMOMETER2Cleared 510(K)
- K952765DELWA-STAR PACIFIER THERMOMETER2Cleared 510(K)
- K952159BASIS DIGITAL THERMOMETER2Cleared 510(K)
- K951939TENDER TEMP2Cleared 510(K)
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- K951403R&D BATTERIES PART NOS. 5164, 5252, 5634 AND 56502Cleared 510(K)
- K951402R&D BATTERIES PART NOS. 5167, 5221, 5244 AND 52472Cleared 510(K)
- K951401R&D BATTERIES PART NOS. 5015, 5016, 5037 AND 50512Cleared 510(K)
- K951399R&D BATTERIES PART NOS. 5041 & 56552Cleared 510(K)
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- K951282R&D BATTERIES, INC. PART NUMBERS 5039, 5052, 5056 AND 50612Cleared 510(K)
- K951281R&D BATTERIS, INC. PART NUMBER 5024, 5027, 5033 AND 50352Cleared 510(K)
- K951280R&D BATTERIES, INC. PART NUMBERS 5003, 5006, 5008 AND 50122Cleared 510(K)
- K951279R&D BATTEERIES, INC. PART NUMBERS 5173, 5178, 5197 AND 51992Cleared 510(K)
- K951278R&D BATTERIES, INC. PART NUMBERS 5213, 5222, 5268 AND 52842Cleared 510(K)
- K951277R&D BATTERIES, INC. PART NUMBERS 5295, 5334, 5344 AND 54102Cleared 510(K)
- K951276R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 54382Cleared 510(K)
- K951275R&D BATTERIES, INC. PART NUMBERS 5453, 5474, 5513 AND 55952Cleared 510(K)
- K951274R&D BATTRIES, INC. PART NUMBERS 5601, 5602, 5624 AND 56262Cleared 510(K)
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- K943362PACIFIER-THERMOMETER2Cleared 510(K)
- K943270SURFACE TEMPERATURE PROBES2Cleared 510(K)
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- K935267B-D DIGITAL THERMOMETER2Cleared 510(K)
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- K903501RADIANT TEMPERATUR INDICATOR MODEL 25E2Cleared 510(K)
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- K885187MODEL 1000 ELECTRONIC CLINICAL THERMOMETER2Cleared 510(K)
- K884765CLINICAL ELECTRONIC THERMOMETERS2Cleared 510(K)
- K881813CHRONODYNAMICS DATA RECORDER (CDR)-1002Cleared 510(K)
- K883793DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)2Cleared 510(K)
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- K880639ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE2Cleared 510(K)
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- K874524MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR2Cleared 510(K)
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- K874523MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR2Cleared 510(K)
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- K771998TEMP-A-LERT MODEL TA-9862Cleared 510(K)
- K771994ELECTROTHERM MODEL HT-12Cleared 510(K)
- K761255DIGITAL THERMOMETER2Cleared 510(K)
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- K760948THERMO FINER CORETEMP2Cleared 510(K)
- K760720MON-A-THERM TEMPARATURE MONITOR SYS2Cleared 510(K)
- K760421THERMOMETER, SURVALENT-ELECTRONIC2Cleared 510(K)
- K760118THERMOMETER, DIGITAL FEVER (MEDITEMP)2Cleared 510(K)
- FLNMonitor, Electric For Gravity Flow Infusion Systems2Product Code
- FMJManometer, Spinal-Fluid2Product Code
- FQAScale, Surgical Sponge1Product Code
- FQZThermometer, Clinical Color Change1Product Code
- FRCIndicator, Biological Sterilization Process2Product Code
- FRIScale, Stand-On, Patient1Product Code
- FRWScale, Patient1Product Code
- JOJIndicator, Physical/Chemical Sterilization Process2Product Code
- KMIMonitor, Bed Patient1Product Code
- KPDStrip, Temperature, Forehead, Liquid Crystal2Product Code
- LHBTimer, Apgar1Product Code
- LRTIndicator, Sterilization2Product Code
- MRBIndicator, Biological, Liquid Chemical Sterilization Process2Product Code
- MRLScale, Sponge, Surgical, Electrically-Powered1Product Code
- MTCIndicator, Chemical, Enzymatic, Sterilization Process2Product Code
- OCIIndicator, Physical/Chemical, Storage Temperature2Product Code
- OZKThermometer, Exhaled Breath2Product Code
- PJOFall Prevention Alarm/Sensor Combination Attached Or Unattached1Product Code
- PJPFall Prevention Alarm/Sensor Attached Only1Product Code
- PWWFever Monitoring Kit2Product Code
- PXHThermometer Kit2Product Code
- QKMA Chemical Vapor Sterilization Multivariable Chemical Indicator2Product Code
- SBOBed-Patient Activity Monitoring System1Product Code
- SDVClinical Electronic Thermometer2Product Code
- SDWStationary Infrared Thermometer2Product Code
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
UP-GRADE AND UP-GRADE PRO
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K983887
- 510(k) Type
- Traditional
- Applicant
- Medisim, Ltd.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/12/1999
- Days to Decision
- 102 days
- Submission Type
- Summary