Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- QLSPulse Oximeter For Low-Acuity Settings2Product Code
- PGJOximeter, Wellness2Product Code
- DPZOximeter, Ear2Product Code
- DQAOximeter2Product Code
- K232520Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH2Cleared 510(K)
- K240092Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)2Cleared 510(K)
- K234110Belun Ring BLR-200 (BLR-200)2Cleared 510(K)
- K240808Pulse Oximeter (WS20A)2Cleared 510(K)
- K233827OxiWear2Cleared 510(K)
- K231979Mecun SpO2 sensor2Cleared 510(K)
- K232989Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)2Cleared 510(K)
- K232975Pulse Oximeter (MD300C228)2Cleared 510(K)
- K240305ANNE Limb2Cleared 510(K)
- K223399AViTA Pulse Oximeter2Cleared 510(K)
- K232495Sempulse Halo Vital Signs Monitor2Cleared 510(K)
- K231288Vyvo2Cleared 510(K)
- K230277Pulse Oximeter(Model OHT60,OXH78)2Cleared 510(K)
- K231531Pediarity™2Cleared 510(K)
- K223721Masimo Stork2Cleared 510(K)
- K230587Wrist Pulse Oximeter2Cleared 510(K)
- K231243Finger Clip Pulse Oximeter2Cleared 510(K)
- K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue2Cleared 510(K)
- K221361circul™ pro Ring2Cleared 510(K)
- K230172Pulse Oximeter2Cleared 510(K)
- K211143Pulse Oximeter2Cleared 510(K)
- K222597BabySat 32Cleared 510(K)
- K221798Finger Pulse Oximeter, Model: X1906P2Cleared 510(K)
- K213676Masimo Rad-G with Temperature2Cleared 510(K)
- K220101Pulse Oximeter2Cleared 510(K)
- K213431Handheld Pulse Oximeter2Cleared 510(K)
- K222010Biobeat Platform-2 and BB-613WP Patch2Cleared 510(K)
- K213430Fingertip Pulse Oximeter2Cleared 510(K)
- K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)2Cleared 510(K)
- K213984Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)2Cleared 510(K)
- K221282Empatica Health Monitoring Platform2Cleared 510(K)
- K220351Polso Watch2Cleared 510(K)
- K203812Oxyfit Pulse Oximeter2Cleared 510(K)
- K221979Pulse Oximeter (Model C101A2, C101B1, C101A3)2Cleared 510(K)
- K212385YUWELL Finger Pulse Oximeter2Cleared 510(K)
- K221953Masimo CARESCAPE SpO2 – Masimo with SpHb2Cleared 510(K)
- K212665Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)2Cleared 510(K)
- K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System2Cleared 510(K)
- K213515WesperO22Cleared 510(K)
- K212752Med-link Pulse Oximeter2Cleared 510(K)
- K212555Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC2Cleared 510(K)
- K212153Biobeat Platform, BB-613WP Patch2Cleared 510(K)
- K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O22Cleared 510(K)
- K212300Pulse Oximeter2Cleared 510(K)
- K211400Pulse Oximeter2Cleared 510(K)
- K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)2Cleared 510(K)
- K210305Pulse Oximeter2Cleared 510(K)
- K211407Belun Ring BLR-100X2Cleared 510(K)
- K212876Carescape SpO2 - Masimo2Cleared 510(K)
- K210032Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)2Cleared 510(K)
- K210274Fingertip Pulse Oximeter2Cleared 510(K)
- K201887VS Newborn Heart Rate Monitor2Cleared 510(K)
- K203854Pulse Oximeter2Cleared 510(K)
- K202776Fingertip pulse oximeter2Cleared 510(K)
- K202743Med-Link Temp-pulse Oximeter2Cleared 510(K)
- K201468Pulse Oximeter2Cleared 510(K)
- K202324Fingertip Pulse Oximeter2Cleared 510(K)
- K202173Pulse Oximeter2Cleared 510(K)
- K201384Pulse Oximeter2Cleared 510(K)
- K202851Spo2 Sensor2Cleared 510(K)
- K201294Pulse Oximeter2Cleared 510(K)
- K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor2Cleared 510(K)
- K200414Pulse Oximeter2Cleared 510(K)
- K201360Reusable and Disposable SpO2 Sensors2Cleared 510(K)
- K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable2Cleared 510(K)
- K200537Oxxiom2Cleared 510(K)
- K192900H500 Multi-Sensing Oximetry System2Cleared 510(K)
- K193350Leadtek Fingertip Pulse Oximeter2Cleared 510(K)
- K191574OxSAT 1002Cleared 510(K)
- K200069Disposable SpO2 Sensor2Cleared 510(K)
- K192608Disposable SpO2 Sensor2Cleared 510(K)
- K192343Patient Monitor2Cleared 510(K)
- K191403Pulse Oximeter2Cleared 510(K)
- K191279Disposable SpO2 Sensor2Cleared 510(K)
- K191088Checkme O2 Pulse Oximeter2Cleared 510(K)
- K191430Pulse Oximeter2Cleared 510(K)
- K191420Reusable SpO2 Sensor2Cleared 510(K)
- K191417Belun Ring2Cleared 510(K)
- K190869Pulse Oximeter2Cleared 510(K)
- K190792BB-613WP2Cleared 510(K)
- K190399Beddr 200 System2Cleared 510(K)
- K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System2Cleared 510(K)
- K183277SpO2 Sensor2Cleared 510(K)
- K181352Loop System2Cleared 510(K)
- K182887Masimo Rad-67 Pulse CO-Oximeter and Accessories2Cleared 510(K)
- K181738Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors2Cleared 510(K)
- K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System2Cleared 510(K)
- K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System2Cleared 510(K)
- K183556oCare Wrist Pulse Oximeter2Cleared 510(K)
- K181956Masimo MightySat Rx Fingertip Pulse Oximeter2Cleared 510(K)
- K180380vital signs monitor2Cleared 510(K)
- K180685AS-3XX Series Fingertip Pulse Oximeter2Cleared 510(K)
- K172792Handheld Pulse Oximeter, Model SP-202Cleared 510(K)
- K180046Masimo Rad-97 and Accessories2Cleared 510(K)
- K181503Fingertip Pulse Oximeter2Cleared 510(K)
- K181006BB-613 Watch Oximeter2Cleared 510(K)
- K181270Disposable SpO2 Sensors, Reusable SpO2 Sensors2Cleared 510(K)
- K173368Reusable & Disposable SpO2 Sensors2Cleared 510(K)
- K172492Optical Topography System ETG-41002Cleared 510(K)
- K173123Pulse Oximeter2Cleared 510(K)
- K172616Pulse Oximeter2Cleared 510(K)
- K172981Reusable SpO2 Sensors, Disposable SpO2 Sensors2Cleared 510(K)
- K173045Oximeter2Cleared 510(K)
- K180174Belun Ring2Cleared 510(K)
- K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor2Cleared 510(K)
- K172141Pulse Oximeter2Cleared 510(K)
- K171241Pulse Oximeter2Cleared 510(K)
- K172366Wrist Pulse Oximeter2Cleared 510(K)
- K172482The Nellcor pulse oximetry monitor interface cable2Cleared 510(K)
- K170965Fingertip Pulse Oximeter2Cleared 510(K)
- K163135Finger Pulse Oximeter2Cleared 510(K)
- K171423Nasal Alar SpO2 Sensor2Cleared 510(K)
- K163382Oxitone 10002Cleared 510(K)
- K161938Fingertip Pulse Oximeter2Cleared 510(K)
- K162580Guardian Angel GA1000 Digital Vital Sign Monitoring System2Cleared 510(K)
- K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)2Cleared 510(K)
- K153184Caremed Reusable & Disposable SPO2 Sensors2Cleared 510(K)
- K162675Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter2Cleared 510(K)
- K160231Model X-100C CO-Met™ Oximetry System2Cleared 510(K)
- K160940Masimo Disposable Transflectance Forehead Sensor2Cleared 510(K)
- K153021Fingertip Pulse Oximeter A3102Cleared 510(K)
- K160268Fingertip Pulse Oximeter MD300CG11/MD300CG512Cleared 510(K)
- K161560Fingertip Pulse Oximeter MD300CN3102Cleared 510(K)
- K160582WiCap2Cleared 510(K)
- K152390Medke Oximetry Finger Sensor2Cleared 510(K)
- K152091Fingertip Pulse Oximeter2Cleared 510(K)
- K152089Wrist Pulse Oximeter2Cleared 510(K)
- K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso2Cleared 510(K)
- K152563Pulse Oximeter (MD300M/MD300K2)2Cleared 510(K)
- K151024Finger Type Pulse Oximeter2Cleared 510(K)
- K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D2Cleared 510(K)
- K150314Masimo MightySat Rx Fingertip Pulse Oximeter2Cleared 510(K)
- K151206Fingertip Pulse Oximeter2Cleared 510(K)
- K150093Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-12Cleared 510(K)
- K141362PULSE OXIMETER CMS50EW2Cleared 510(K)
- K142687Pulse Oximeter2Cleared 510(K)
- K142865Nellcor Bedside SpO2 Patient Monitoring System2Cleared 510(K)
- K142959Vyntus Walk2Cleared 510(K)
- K143216Assurance Alar / Nasal SpO2 Sensor2Cleared 510(K)
- K141518Nellcor Bedside Respiratory Patient Monitoring System2Cleared 510(K)
- K142888Fingertip Pulse Oximeter2Cleared 510(K)
- K142832Unimed Disposable and Reusable SPO2 Sensors2Cleared 510(K)
- K142209Pulse oximeter NBM-2002Cleared 510(K)
- K141024EXTERNAL PULSE OXIMETER2Cleared 510(K)
- K141105PULSE OXIMETER2Cleared 510(K)
- K141542NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )2Cleared 510(K)
- K140582FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K141128FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K132516OXIPROBE E (OXIPROBE)2Cleared 510(K)
- K140682FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K140785PULSE OXIMETER2Cleared 510(K)
- K133064MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-312Cleared 510(K)
- K133090OXICARE FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K132402SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM2Cleared 510(K)
- K130320BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW2Cleared 510(K)
- K124041NBM-200MP2Cleared 510(K)
- K131047FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K130947FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K132696TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR2Cleared 510(K)
- K131111IHEALTH FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K131021PULSE OXIMETER2Cleared 510(K)
- K131818VITAL SIGNS MONITOR2Cleared 510(K)
- K123797NT1D VITAL SIGNS MONITOR2Cleared 510(K)
- K123801FINGER PULSE OXIMETER2Cleared 510(K)
- K123871FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K123581NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN2Cleared 510(K)
- K120984MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR2Cleared 510(K)
- K122996ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 100852Cleared 510(K)
- K113727SHENZHEN MED-LINK PULSE OXIMETER PROBE2Cleared 510(K)
- K122046WRIST PULSE OXIMETER2Cleared 510(K)
- K122927OXICARE FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K120502PC-60NW FINGERTIP OXIMETER2Cleared 510(K)
- K121697FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K121806BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE2Cleared 510(K)
- K120657MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS2Cleared 510(K)
- K121914MASIMO SET USPO2 PULSE OXIMETRY CABLE2Cleared 510(K)
- K120052CVINSIGHT2Cleared 510(K)
- K121912E1 EAR SENSORS2Cleared 510(K)
- K120773NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM2Cleared 510(K)
- K112843PULSE OXIMETER2Cleared 510(K)
- K113865PULTOL2Cleared 510(K)
- K113596MASIMO SET REUSABLE OXIMETRY SENSORS2Cleared 510(K)
- K112804FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K111494HANDHELD PULSE OXIMETER2Cleared 510(K)
- K111403MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES2Cleared 510(K)
- K111617PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M12Cleared 510(K)
- K110893VTRUST FINGER TYPE PULSE OXIMETER2Cleared 510(K)
- K111621MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS2Cleared 510(K)
- K111888MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS2Cleared 510(K)
- K112465VITAL SIGNS MONITOR2Cleared 510(K)
- K103802TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR2Cleared 510(K)
- K103285DIXTAL DZ-4100 SERIES PULSE OXIMETER2Cleared 510(K)
- K103685PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA2Cleared 510(K)
- K103584ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS2Cleared 510(K)
- K110028MASIMO RADICAL Y PULSE CO-OXIMETER2Cleared 510(K)
- K103700ESSENTIAL MRI PATIENT MONITOR2Cleared 510(K)
- K102270ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN2Cleared 510(K)
- K100225PULSE OXIMETER MODEL P102Cleared 510(K)
- K101995CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD2Cleared 510(K)
- K102835VITAL SIGNS MONITOR2Cleared 510(K)
- K102350PULSE OXIMETER2Cleared 510(K)
- K101012V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-82012Cleared 510(K)
- K101577MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES2Cleared 510(K)
- K101539VITAL SIGNS MONITOR MODEL M3B2Cleared 510(K)
- K101031MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E12Cleared 510(K)
- K101896MASIMO LNCS/M-LNCS OXIMETRY SENSORS2Cleared 510(K)
- K092641CHARMCARE TABLETOP PULSE OXIMETER2Cleared 510(K)
- K100077NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-0901032Cleared 510(K)
- K101871TRUSIGNAL SPO2 FINGERTIP SENSOR2Cleared 510(K)
- K101568MODEL SB100II FINGER PULSE OXIMETER2Cleared 510(K)
- K102442E.S.O. (ELECTRO SENSOR OXI)2Cleared 510(K)
- K101694HANDHELD PULSE OXIMETER MODEL M8002Cleared 510(K)
- K101600INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL2Cleared 510(K)
- K100428MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER2Cleared 510(K)
- K100403MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-72Cleared 510(K)
- K100815OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C3162Cleared 510(K)
- K093853SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES2Cleared 510(K)
- K100617MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D2Cleared 510(K)
- K100203HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M2Cleared 510(K)
- K094046LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS2Cleared 510(K)
- K093016VITAL SIGNS MONITOR2Cleared 510(K)
- K091564NBM-200MP PULSE OXIMETRY DEVICE2Cleared 510(K)
- K093881TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR2Cleared 510(K)
- K092950SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES2Cleared 510(K)
- K100020DX SERIES FINGER SENSOR2Cleared 510(K)
- K093306SINGLE-PATIENT USE DISPOSABLE SENSOR2Cleared 510(K)
- K093757MD300C1 FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K092652FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA2Cleared 510(K)
- K092620MD300C318 FINGERTIP PULSE OXIMETER2Cleared 510(K)
- K092727H100B PULSE OXIMETER2Cleared 510(K)
- K092549OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P2Cleared 510(K)
- K091241MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER2Cleared 510(K)
- K092101REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES2Cleared 510(K)
- K092838MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 82Cleared 510(K)
- K091787MODEL 6000 TWO PARAMETER BEDSIDE MONITOR2Cleared 510(K)
- K092678EVISION DATA MANAGEMENT SOFTWARE2Cleared 510(K)
- K091572DISPOSABLE SPO2 SENSOR M1134A2Cleared 510(K)
- K092324SPIROPRO2Cleared 510(K)
- K083448CABLE, TRANSDUCER, MODEL 2400GN2Cleared 510(K)
- K090662MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP2Cleared 510(K)
- K090438REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR2Cleared 510(K)
- K090599MD300K1 PULSE OXIMETER2Cleared 510(K)
- K091057MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES2Cleared 510(K)
- K090165RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-202Cleared 510(K)
- K090671PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D2Cleared 510(K)
- K083010SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR2Cleared 510(K)
- K083821VITAL SIGNS MONITOR2Cleared 510(K)
- K090360PHILIPS M3001A MULTI MEASUREMENT SERVER2Cleared 510(K)
- K083557BCI WW1030 PULSE OXIMETER2Cleared 510(K)
- K090205BCI WW1021 PC APPLICATION2Cleared 510(K)
- K083351PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P2Cleared 510(K)
- K083787BCI WW1000 PULSE OXIMETER, MODEL WW10002Cleared 510(K)
- K083705BCI WW1020 PULSE OXIMETER, MODEL WW10202Cleared 510(K)
- K083466MD2000A VITAL SIGN MONITOR, MODEL MD2000A2Cleared 510(K)
- K082846APK SPO2 PULSE OXIMETER SENSOR2Cleared 510(K)
- K083622LNCS OXIMETRY SENSORS2Cleared 510(K)
- K083892FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)2Cleared 510(K)
- K083325N-600X WITH SPD, OXIMAX N-600X2Cleared 510(K)
- K083079QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH1002Cleared 510(K)
- K082487M-50 SERIES SPO2 SENSOR2Cleared 510(K)
- K082268CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX2Cleared 510(K)
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- K9914103402 HANDHELD PULSE OXIMETER2Cleared 510(K)
- K990966MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS2Cleared 510(K)
- K991661SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER2Cleared 510(K)
- K990082EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-092Cleared 510(K)
- K982728NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C2Cleared 510(K)
- K983684DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS2Cleared 510(K)
- K9827769303 NEONATAL/ADULT VITAL SIGNS MONITOR2Cleared 510(K)
- K982255MODEL 2000 PULSE OXIMETER2Cleared 510(K)
- K973970SPO2 FINGER PROBES2Cleared 510(K)
- K982907MAGNATEK 402Cleared 510(K)
- K982405MTEK-10002Cleared 510(K)
- K982331KELLER PULSE OXIMETER, MODEL 850+2Cleared 510(K)
- K981939AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR2Cleared 510(K)
- K980879OSCILLOMATE NIBP / SP02 EMS MONITOR2Cleared 510(K)
- K974292NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES2Cleared 510(K)
- K970098E100 SERIES SPO2 SENSORS2Cleared 510(K)
- K980299APEX OXIMETER2Cleared 510(K)
- K980714BCI 3401 HANDHELD PULSE OXIMETER2Cleared 510(K)
- K973991METRON QA-510 SPO2 ANALYZER2Cleared 510(K)
- K973887MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES2Cleared 510(K)
- K973147NPB-295 PULSE OXIMETER2Cleared 510(K)
- K972829CRICKET 2000 RECORDING PULSE OXIMETER2Cleared 510(K)
- K972837NPB-290 PULSE OXIMETER (NPB-290)2Cleared 510(K)
- K972786ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL93662Cleared 510(K)
- K971628SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)2Cleared 510(K)
- K971273INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF2Cleared 510(K)
- K972468NPB-195 PULSE OXIMETER2Cleared 510(K)
- K970061ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)2Cleared 510(K)
- K973222SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER2Cleared 510(K)
- K970769COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR2Cleared 510(K)
- K971946NPB-190 PULSE OXIMETER (NPB-190)2Cleared 510(K)
- K971827ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS717642Cleared 510(K)
- K971828ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-01152Cleared 510(K)
- K965172OXIMETER PRE-AMP CABLE2Cleared 510(K)
- K964821COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS672Cleared 510(K)
- K970763MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR2Cleared 510(K)
- K971235ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W2Cleared 510(K)
- K964978VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)2Cleared 510(K)
- K970368SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER2Cleared 510(K)
- K964055FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)2Cleared 510(K)
- K9452908500A PULSE OXIMETER2Cleared 510(K)
- K962603MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES2Cleared 510(K)
- K963707NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)2Cleared 510(K)
- K952315SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE2Cleared 510(K)
- K963496OXI TEMP2Cleared 510(K)
- K962127OHMEDA 3800 PULSE OXIMETER2Cleared 510(K)
- K954168E100A PULSE OXIMETER FINGER SENSOR/PROBE2Cleared 510(K)
- K9621563304 PULSE OXIMETER2Cleared 510(K)
- K961450SCORE SOFTWARE2Cleared 510(K)
- K960614SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)2Cleared 510(K)
- K960058OXITEMP, 3301T SA2Cleared 510(K)
- K954267BURDICK 200 PULSE OXIMETER2Cleared 510(K)
- K960251COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR2Cleared 510(K)
- K9409339267 SPO2 ATHENA MODULE2Cleared 510(K)
- K953817ARISTO MEDICAL MODEL 2101 PATIENT MONITOR2Cleared 510(K)
- K953126OXILINK (SMALL, MEDIUM, LARGE)2Cleared 510(K)
- K952327SMARTSAT PULSE OXIMETRY ANALYZER2Cleared 510(K)
- K952316NELLCOR SYMPHONY N-3000 PULSE OXIMETER2Cleared 510(K)
- K952222NELLCOR N-20PA PORTABLE PULSE OXIMETER2Cleared 510(K)
- K945754NEWOX22Cleared 510(K)
- K942347NELLCOR SYMPHONY PULSE OXIMETER MODEL N-30002Cleared 510(K)
- K943842PULSE OXIMETER MODEL 3052Cleared 510(K)
- K9461853301T OXITEMP2Cleared 510(K)
- K942842HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE2Cleared 510(K)
- K945464FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE2Cleared 510(K)
- K942248MINIATURIZED FINGER CLIP PULSE OXIMETER2Cleared 510(K)
- K943817MARQUETTE ADULT/NEONATAL WRAP SENSOR2Cleared 510(K)
- K943456AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT2Cleared 510(K)
- K9434043301 PULSE OXIMETER2Cleared 510(K)
- K941351BURDICK PRO2 OXIMETER2Cleared 510(K)
- K944608HP M1722A/B AND M1723A/B CODEMASTER2Cleared 510(K)
- K931304OHMEDA HAND HELD OXIMETER2Cleared 510(K)
- K933519INDEX SPO2 SIMULATOR2Cleared 510(K)
- K933755SENSOR SHIELD, MODIFICATION2Cleared 510(K)
- K932203VITALMAX 5302Cleared 510(K)
- K935510VX4 RECORDING PULSE OXIMETER2Cleared 510(K)
- K941289PULSE OXIMETER2Cleared 510(K)
- K920083BIOCHEM MODEL 3302 NEWOX2 OXIMETER2Cleared 510(K)
- K921454FUKUDA DENSHI MODEL HG-3012Cleared 510(K)
- K934091OXISAT2Cleared 510(K)
- K940463NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS2Cleared 510(K)
- K924626NOVAMETRIX MODEL 5102Cleared 510(K)
- K924752FREEDOM OXIMETER/EEG DIGITAL INTERFACE2Cleared 510(K)
- K920966SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)2Cleared 510(K)
- K915699NELLCOR PORTABLE PULSE OXIMETER MODEL N-202Cleared 510(K)
- K924285MODEL 3500 MR-COMPATIBLE PULSE OXIMETER2Cleared 510(K)
- K924282MODEL 320 MR-COMPATIBLE PULSE OXIMETER2Cleared 510(K)
- K920066PALCO LABS MODEL 340 PULSE OXIMETER2Cleared 510(K)
- K9234189293/1 INTERFACE MODULE2Cleared 510(K)
- K925542OXYSHUTTLE II ,MODIFICATION2Cleared 510(K)
- K923343HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER2Cleared 510(K)
- K920082BIOCHEM MODEL 3301 NEWOX1 OXIMETER2Cleared 510(K)
- K910811SENSOR SHIELD2Cleared 510(K)
- K922075AVOXIMETER2Cleared 510(K)
- K921519OXICOM-21002Cleared 510(K)
- K923682MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE2Cleared 510(K)
- K920379NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX2Cleared 510(K)
- K914538UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER2Cleared 510(K)
- K915773P-300 CAPNOGRAPH AND PULSE OXIMETER2Cleared 510(K)
- K910077CRIT-SCAN2Cleared 510(K)
- K914620HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION2Cleared 510(K)
- K913790SENSORMEDICS OXYSHUTTLE II(TM)2Cleared 510(K)
- K912880VITALMAX 510/5202Cleared 510(K)
- K913695NELLCOR(R) N-180 PULSE OXIMETER2Cleared 510(K)
- K913516MODEL 520A NOVAMETRIX PULSE OXIMETER2Cleared 510(K)
- K911761SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION2Cleared 510(K)
- K913489SIEMENS MICRO2 PULSE OXIMETER2Cleared 510(K)
- K913332CIBA CORNING MODEL 270 CO-OXIMETER2Cleared 510(K)
- K911207OXICOMPLUS2Cleared 510(K)
- K910001MODEL 8604-FO PULSE OXIMETER2Cleared 510(K)
- K911191PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR2Cleared 510(K)
- K911124503 PULSE OXIMETER2Cleared 510(K)
- K905310MINIOX V PULSE OXIMETER2Cleared 510(K)
- K905140SATLITE PLUS PULSE OXIMETER2Cleared 510(K)
- K910770504US PULSE OXIMETER2Cleared 510(K)
- K910629AP-860PA NIBP MODULE2Cleared 510(K)
- K910521SYSTEM 7300 PULSE OXIMETER2Cleared 510(K)
- K904988PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR2Cleared 510(K)
- K904088ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC2Cleared 510(K)
- K904039REFLECTANCE SENSOR (RS-10)2Cleared 510(K)
- K900001COROMETRICS MODEL 556 NEONATAL MONITOR2Cleared 510(K)
- K903523HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE2Cleared 510(K)
- K902730SPO2 OPTION2Cleared 510(K)
- K903702MODEL 90421 FLEXPORT INTERFACE2Cleared 510(K)
- K902779MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA2Cleared 510(K)
- K901066VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA.2Cleared 510(K)
- K902758COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC2Cleared 510(K)
- K902192MODEL MSC SA02-5000 PULSE OXIMETER2Cleared 510(K)
- K901504MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP.2Cleared 510(K)
- K900757ITC ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K896738TYPE 9293 INTERFACE PULSEOX2Cleared 510(K)
- K901819MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)2Cleared 510(K)
- K901071PULSE OXIMETRY MODULE2Cleared 510(K)
- K901399POWERBASE II (PB2)2Cleared 510(K)
- K902060ESCORT MODEL 3002Cleared 510(K)
- K901774HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL2Cleared 510(K)
- K892217CAV SAT OXIMETER MODEL 1002Cleared 510(K)
- K901060EDENTEC MODEL 2000W SYSTEM 700 MONITOR2Cleared 510(K)
- K894100OXYTRAK(TM) PULSE OXIMETER2Cleared 510(K)
- K901612VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE2Cleared 510(K)
- K901209MODEL 90489 PULSE OXIMETER MODULE2Cleared 510(K)
- K900866OXIMAX 7002Cleared 510(K)
- K900843OXIMAX 1002Cleared 510(K)
- K893221MODEL 8500 HAND HELD PULSE OXIMETER2Cleared 510(K)
- K895987KELLER PULSE OXIMETER - KMS 8502Cleared 510(K)
- K893643NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER2Cleared 510(K)
- K895425MINIMON 7137B PATIENT MONITOR2Cleared 510(K)
- K892120ESCORT PULSE OXIMETRY OPTION2Cleared 510(K)
- K893867CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE2Cleared 510(K)
- K893587OXIMETER2Cleared 510(K)
- K893470SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE2Cleared 510(K)
- K884121TYPE 9266 SAO2 SYSTEM ATHENA2Cleared 510(K)
- K890753SATLITE TRANS PORTABLE PULSE OXIMETER2Cleared 510(K)
- K890299KONTRON PULSE OXIMETER 78402Cleared 510(K)
- K884822MODEL OX-1 OXYGEN SATURATION MODULE2Cleared 510(K)
- K884050CNS-8200A CENTRAL NURSES STATION2Cleared 510(K)
- K890033MODEL 8700 PULSE OXIMETER2Cleared 510(K)
- K884536AL-800PA PULSE OXIMETER MODULE2Cleared 510(K)
- K884614EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.2Cleared 510(K)
- K884891OC-100 OXIMETER INTERFACE CALIBRATOR2Cleared 510(K)
- K884329SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER2Cleared 510(K)
- K881307OLV 1100; OLV 1200 PULSE OXIMETERS2Cleared 510(K)
- K883877BM-103 BATTERY MODULE2Cleared 510(K)
- K873624KONTRON PULSE OXIMETER 78402Cleared 510(K)
- K883297HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER2Cleared 510(K)
- K880756MODEL PM-20A PHYSIOLOGICAL MONITOR2Cleared 510(K)
- K882664MRL OXIMETER2Cleared 510(K)
- K882273HORIZON 2000 PULSE OXIMETRY AND MODULE2Cleared 510(K)
- K881883SATLITE+/PB251+ PULSE OXIMETER2Cleared 510(K)
- K881820EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER2Cleared 510(K)
- K881136HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.2Cleared 510(K)
- K880672SENTINEL PULSE OXIMETER2Cleared 510(K)
- K872520SS-1000 POLYGRAPH2Cleared 510(K)
- K874492LAWRENCE L4000 REFLECTANCE PULSE OXIMETER2Cleared 510(K)
- K874198VITALOG HMS-30002Cleared 510(K)
- K875298502-US PULSE OXIMETER2Cleared 510(K)
- K873896SIMED S-100 PULSE OXIMETER2Cleared 510(K)
- K874442DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER2Cleared 510(K)
- K875031OXYGEN/PULSE MONITOR2Cleared 510(K)
- K874947MODEL 8800 CARDIORESPIRATORY OXIMETER2Cleared 510(K)
- K874692PULSEMATE BX-52Cleared 510(K)
- K873199OHMEDA 4700 OXICAP MONITOR2Cleared 510(K)
- K874132MINIOX IV PORTABLE PULSE OXIMETER2Cleared 510(K)
- K873859CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-1042Cleared 510(K)
- K874104OHMEDA BIOX 3760 PULSE OXIMETER2Cleared 510(K)
- K873081EDENTEC MULTI-CHANNEL RECORDER2Cleared 510(K)
- K873065MODEL 7200A WITH PULSE OXIMETRY2Cleared 510(K)
- K872772OHMEDA BIOX 3740 PULSE OXIMETER2Cleared 510(K)
- K863857PULSE-OX2Cleared 510(K)
- K873078NOVAMETRIX MODEL 505 PULSE OXIMETER2Cleared 510(K)
- K872626OXIMETRY MODULE2Cleared 510(K)
- K871826PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE2Cleared 510(K)
- K871864PB240 PATIENT MONITOR/PULSE OXIMETER2Cleared 510(K)
- K871353OXIMETER2Cleared 510(K)
- K864730INVIVO PULSE OXIMETER, MODEL 45002Cleared 510(K)
- K870621SATLITE/PB251 PULSE OXIMETER2Cleared 510(K)
- K864279SPACELABS MODEL 90419 PULSE OXIMETER MODULE2Cleared 510(K)
- K864613502 OXYGEN SATURATION MONITOR2Cleared 510(K)
- K870163BIOCHEM MICROSPAN 1040 OXIMETER2Cleared 510(K)
- K863918MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT.2Cleared 510(K)
- K863855ACCUSAT2Cleared 510(K)
- K862812NELLCOR MVP, MODEL N-10002Cleared 510(K)
- K863784NELLCOR N-200 (PULSE OXIMETER)2Cleared 510(K)
- K863186BIOCHEM CO/OX 10002Cleared 510(K)
- K862617SENSORMEDICS OXYSHUTTLE(TM)2Cleared 510(K)
- K862798MINIOX 100 PULSE OXIMETER2Cleared 510(K)
- K862161OSC-80 OXIMETER2Cleared 510(K)
- K860051MODEL 8604 OXYGEN/PULSE MONITOR2Cleared 510(K)
- K855027PULSE OXIMETER2Cleared 510(K)
- K844256NELLCOR PULSE OXIMETER N-102Cleared 510(K)
- K833973MINOLTA SM-32 OXYGEN SATURATION MONIT2Cleared 510(K)
- K833826BTI BIOX III OXIMETER CRITICAL CAREUNI2Cleared 510(K)
- K822909PULSE OXIMETER MODEL 1002Cleared 510(K)
- K820110BIOX III2Cleared 510(K)
- K781879HEATER, OXIMETER SYSTEM2Cleared 510(K)
- K780625UNISTAT OXIMETER2Cleared 510(K)
- NLFOximeter, Reprocessed2Product Code
- OLKPulse Oximeter For Over-The-Counter Use2Product Code
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular 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—MiscellaneousCFR Sub-Part
- CardiovascularReview Panel
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- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
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- OphthalmicReview Panel
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- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K002036
- 510(k) Type
- Traditional
- Applicant
- OSI MEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/17/2001
- Days to Decision
- 286 days
- Submission Type
- Summary