Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- BSEAnalyzer, Gas, Helium, Gaseous-Phase2Product Code
- BSIAlgesimeter, Powered2Product Code
- BTYCalculator, Predicted Values, Pulmonary Function2Product Code
- BXAAnalyzer, Gas, Water Vapor, Gaseous-Phase1Product Code
- BXLAlgesimeter, Manual1Product Code
- BXQRhinoanemometer (Measurement Of Nasal Decongestion)2Product Code
- BXRMeter, Airway Pressure (Inspiratory Force)2Product Code
- BXWCalibrator, Volume, Gas1Product Code
- BZCCalculator, Pulmonary Function Data2Product Code
- BZGSpirometer, Diagnostic2Product Code
- BZHMeter, Peak Flow, Spirometry2Product Code
- BZKSpirometer, Monitoring (W/Wo Alarm)2Product Code
- BZLComputer, Oxygen-Uptake2Product Code
- BZMCalculator, Pulmonary Function Interpretor (Diagnostic)2Product Code
- BZSStethoscope Head1Product Code
- BZTStethoscope, Esophageal, With Electrical Conductors2Product Code
- BZWStethoscope, Esophageal1Product Code
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)2Product Code
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)2Product Code
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)2Product Code
- CBTArterial Blood Sampling Kit1Product Code
- CBZAnalyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling2Product Code
- CCCAnalyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling2Product Code
- CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling2Product Code
- CCIAnalyzer, Gas, Nitrogen, Gaseous-Phase2Product Code
- CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase2Product Code
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase2Product Code
- K222511Oxy2Pro2Cleared 510(K)
- K213767Endure ETCO2/02 Nasal Cannula2Cleared 510(K)
- K221118CO2 Mainstream Sensor2Cleared 510(K)
- K210112XChange Device, XChange System2Cleared 510(K)
- K220533Endoscopy Oxygen Mask2Cleared 510(K)
- K213911Microstream CO2 NanoPod2Cleared 510(K)
- K213518CARESCAPE CO2 Microstream parameter2Cleared 510(K)
- K211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories2Cleared 510(K)
- K203762Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector2Cleared 510(K)
- K201590EMMA Capnograph2Cleared 510(K)
- K210019Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+2Cleared 510(K)
- K192488CO2 Sidestream Module2Cleared 510(K)
- K192446CO2 Mainstream Module2Cleared 510(K)
- K200594Capnostream 35 Portable Respiratory Monitor2Cleared 510(K)
- K192563Altera gas Sampling Lines2Cleared 510(K)
- K190824Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric2Cleared 510(K)
- K182362MaxCap Ped and MaxCap Neo2Cleared 510(K)
- K183394CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO2Cleared 510(K)
- K181624Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line2Cleared 510(K)
- K181467Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line2Cleared 510(K)
- K181981CO2 Sampling Line2Cleared 510(K)
- K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly2Cleared 510(K)
- K170820Capnograph and Oximeter2Cleared 510(K)
- K173147SuperNO2VA Et Device2Cleared 510(K)
- K171828ETCO2 Sensor2Cleared 510(K)
- K171678Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable2Cleared 510(K)
- K172365Panoramic Oxygen Mask (POM)2Cleared 510(K)
- K171235OmniCap2Cleared 510(K)
- K172904IntelliVue Capnography Extension, IntelliVue Microstream Extension2Cleared 510(K)
- K171765Nihon Kohden CO2 Monitor2Cleared 510(K)
- K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories2Cleared 510(K)
- K161250OC-FLEX Flexible IntraOral Cannula2Cleared 510(K)
- K161860TG-970P CO2 Sensor Kit2Cleared 510(K)
- K162343Westmed Gas Sampling Cannula with O2 delivery2Cleared 510(K)
- K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines2Cleared 510(K)
- K150272Capnostream 35 Portable Respiratory Monitor2Cleared 510(K)
- K150245CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX2Cleared 510(K)
- K143127CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style2Cleared 510(K)
- K143469SOFTECH Plus ETCO2 Cannula2Cleared 510(K)
- K143150CO2 monitoring line with and without in-line filter2Cleared 510(K)
- K142467IntelAir Nasal Airway Support System2Cleared 510(K)
- K123690CAPNOSTREAM20P WITH HIFI C02 MONITORING2Cleared 510(K)
- K132946SOFTECH PLUS ETC02 CANNULA2Cleared 510(K)
- K133516CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER2Cleared 510(K)
- K140473DUALGUARD2Cleared 510(K)
- K133540FLOCAP2Cleared 510(K)
- K140113O2 NASAL CANNULA WITH CO2 MONITORING2Cleared 510(K)
- K131506AIRWAY SUPPORT SYSTEM / AIRPORT2Cleared 510(K)
- K131410CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),2Cleared 510(K)
- K133806M1 CAPNOGRAPHY MASK2Cleared 510(K)
- K131339CAPNOMASK2Cleared 510(K)
- K122214TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)2Cleared 510(K)
- K130112CAPNO MODULE, 925172Cleared 510(K)
- K122075DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER2Cleared 510(K)
- K121927MICROSTREAM FILTERLINE ICU2Cleared 510(K)
- K123043IRMA C02 MODEL 200101; IRMA AX 2006012Cleared 510(K)
- K112368CAPNOSTREAM20P WITH AI/ODI2Cleared 510(K)
- K121017CAPNOGRAPHY PAD (92516)2Cleared 510(K)
- K112840CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR2Cleared 510(K)
- K120518END TIDAL CO2 NASAL CANNULA2Cleared 510(K)
- K110594GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS2Cleared 510(K)
- K103604ISA CO2, ISA AX+, ISA OR+2Cleared 510(K)
- K094012CAPNOSTREAM20 WITH MICROMEDICO2 MODULE2Cleared 510(K)
- K100941INFINITY MCABLE - MAINSTREAM CO22Cleared 510(K)
- K093388SMART CAPNOLINE GUARDIAN2Cleared 510(K)
- K093525ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE2Cleared 510(K)
- K083456NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P2Cleared 510(K)
- K083056NEO-STAT CO2 <KG2Cleared 510(K)
- K080527TWINGUARD WITH CAPNOGRAPH ACCESSORY2Cleared 510(K)
- K081601VEO MULTIGAS MONITOR FOR POCKET PC2Cleared 510(K)
- K063813VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA2Cleared 510(K)
- K072813EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)2Cleared 510(K)
- K072843YG-125T AND YG-135T NASAL ADAPTER2Cleared 510(K)
- K072220PEDI CO2 EASY2Cleared 510(K)
- K070128CO2 EASY2Cleared 510(K)
- K063167EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)2Cleared 510(K)
- K062115CARBON DIOXIDE MONITOR, MODEL OLG-2800A2Cleared 510(K)
- K053204INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A2Cleared 510(K)
- K053174LOFLO C5 CO2 SENSOR2Cleared 510(K)
- K053063PRO-FLOW MULTIPURPOSE CANNULA2Cleared 510(K)
- K052880DATEX-OHMEDA S/5 INTERFACE MODULE E-INT2Cleared 510(K)
- K052582DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES2Cleared 510(K)
- K051857VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 4002212Cleared 510(K)
- K052167DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES2Cleared 510(K)
- K050066C-CO2 COLORIMETRIC CO2 INDICATOR2Cleared 510(K)
- K042665SMART BITEBLOC2Cleared 510(K)
- K042601CAPNOSTAT 52Cleared 510(K)
- K040875CAP-ONE, MODEL TG-920P2Cleared 510(K)
- K041956EMG - ESSENTIAL GAS MODULE, MODEL M1013A2Cleared 510(K)
- K041450MODIFICATION TO NICO WITH MARS, MODEL 73002Cleared 510(K)
- K040847MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR2Cleared 510(K)
- K040011POLARIS 2004 CAPNOGRAPH2Cleared 510(K)
- K031741MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 83002Cleared 510(K)
- K030886NICO WITH MARS, MODEL 73002Cleared 510(K)
- K030407ADVISOR, MODEL 92002Cleared 510(K)
- K031814STATCO2METER, MODEL 10-553722Cleared 510(K)
- K031411MINI STATCO2 CO2 DETECTOR, MODEL 10-553712Cleared 510(K)
- K023820CO2 CLIP2Cleared 510(K)
- K023454DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES2Cleared 510(K)
- K023579GAS SAMPLING LINES2Cleared 510(K)
- K021576MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-553702Cleared 510(K)
- K020046MULTIGAS UNIT, MODEL AG-920RA2Cleared 510(K)
- K014211OXYARM CO22Cleared 510(K)
- K012139VAMOS ANESTHETIC GAS MONITOR2Cleared 510(K)
- K013845MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE2Cleared 510(K)
- K011536MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE2Cleared 510(K)
- K012395MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE2Cleared 510(K)
- K012394ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE2Cleared 510(K)
- K012391MAC-LINE CO2 NASAL CANNULA SAMPLE LINE2Cleared 510(K)
- K011050MICROSTREAM ORAL NASAL CANNULA FILTERLINE2Cleared 510(K)
- K010795CAPNOPROBE SL, MODEL 20002Cleared 510(K)
- K010024O2/CO2 NASAL FILTERLINE2Cleared 510(K)
- K003550INFINITY ETCO2 + RESPIRATORY MECHANICS POD2Cleared 510(K)
- K003982TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR2Cleared 510(K)
- K002163MICROSTREAM EXTERNAL BATTERY CHARGER2Cleared 510(K)
- K984579CAPNO PROBE A2Cleared 510(K)
- K001814DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES2Cleared 510(K)
- K000520C-IT2Cleared 510(K)
- K000712PORTABLE INTENSIVE CARE UNIT, MODEL PIC2Cleared 510(K)
- K993656DATEX-OHMEDA TONOMETRY MODULE M-TONO2Cleared 510(K)
- K992116SIEMEMNS INFINITY ETC02 POD2Cleared 510(K)
- K983864ETCO2 VITAL SIGNS MODULE2Cleared 510(K)
- K982969NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 98472Cleared 510(K)
- K991086CAPNOCHECK II, MODEL 84002Cleared 510(K)
- K990063NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES2Cleared 510(K)
- K983114MAGNATEK802Cleared 510(K)
- K982846MTEK-14002Cleared 510(K)
- K981114MICROCAP2Cleared 510(K)
- K980979FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE2Cleared 510(K)
- K973544VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER2Cleared 510(K)
- K980384TRIP TONOMETRY CATHETER, 18F2Cleared 510(K)
- K980324MICROSTREAM FILLERLINE OR/EMS2Cleared 510(K)
- K980325MICROSTREAM NASAL CANNULA FILTERLINE2Cleared 510(K)
- K980327MICROSTREAM FILTERLINE ICU2Cleared 510(K)
- K973984RAC 2A MODULE HOUSING2Cleared 510(K)
- K971229CAPNOXYGEN MASK2Cleared 510(K)
- K964961MODEL 405T WITH ETCO2 OPTION2Cleared 510(K)
- K964239COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER2Cleared 510(K)
- K970209CAPNOCHECK PLUS2Cleared 510(K)
- K962638TONOCAP, TC-200 AND ACCESSORY CATHETERS2Cleared 510(K)
- K954120MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR2Cleared 510(K)
- K964305NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES2Cleared 510(K)
- K963327TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 6102Cleared 510(K)
- K960972DISPOSABLE GAS SAMPLING INTERFACE KITS2Cleared 510(K)
- K961150DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA2Cleared 510(K)
- K954402ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)2Cleared 510(K)
- K954632SIEMENS SC 9000 ETCO2 MODULE2Cleared 510(K)
- K953006AS/3 NETWORK LINK2Cleared 510(K)
- K950044FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE2Cleared 510(K)
- K952325ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)2Cleared 510(K)
- K944052RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR2Cleared 510(K)
- K950387GEMINI2Cleared 510(K)
- K950388POLARIS2Cleared 510(K)
- K950581SMART ANESTHESIA MULTI-GAS (SAM) MODULE2Cleared 510(K)
- K951127HEWLETT-PACKARD MODEL M1026A ANESTHETIC GAS MODULE2Cleared 510(K)
- K943977SMART ANESTHESIA MULTI-GAS (SAM) MODULE2Cleared 510(K)
- K943389SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM2Cleared 510(K)
- K944541HANDYPACK 911SC2Cleared 510(K)
- K942849CAPNOSAT2Cleared 510(K)
- K942113CARBON DIOXIDE ANALYZER (MODEL CD-3A)2Cleared 510(K)
- K946044DISPOSABLE GAS SAMPLING LINES2Cleared 510(K)
- K9419719100 MUTIGAS MONITOR2Cleared 510(K)
- K941982CAPNOCHECK2Cleared 510(K)
- K941165COMET CAPNOGRAPH MODULE2Cleared 510(K)
- K944400PEDI-CAP2Cleared 510(K)
- K925701MINIPACK 911-STC2Cleared 510(K)
- K935477AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD2Cleared 510(K)
- K942772A-200 MULTI-USE AIRWAY ADAPTER2Cleared 510(K)
- K935272CAP 400 AT2Cleared 510(K)
- K933284AS/3 TM NETWORK2Cleared 510(K)
- K942567MASS SPECTROMETRY MONITORING LINES AND CONNECTORS2Cleared 510(K)
- K930524END TIDAL CO2 OPTION B2Cleared 510(K)
- K933707CAPNODIG2Cleared 510(K)
- K930250LOW DEAD SPACE ADAPTOR & REUASABLE AIRWAY ADAPTOR2Cleared 510(K)
- K933980HP M1465A STANDARD AIRWAY ADAPTER2Cleared 510(K)
- K930559VITALMAX 800-C2Cleared 510(K)
- K915494NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-602Cleared 510(K)
- K930957ZEFON GAS SAMPLING LINES2Cleared 510(K)
- K925484CARBON DIOXIDE & OXYGEN MONITOR TYPE 13082Cleared 510(K)
- K930866RASCAL II2Cleared 510(K)
- K925424MEDICAL MANUFACTURING INC GAS SAMPLING LINES&CONN.2Cleared 510(K)
- K921497PROPAQ MONITORS, MODIFICATION2Cleared 510(K)
- K920915CAPNOMED 100 STAND-ALONE ETCO2 MODULE2Cleared 510(K)
- K924083700/700-12Cleared 510(K)
- K925167MASS SPECTROMETRY MONITORING LINE CONONECTORS2Cleared 510(K)
- K923305BATTERY PACKS2Cleared 510(K)
- K913995VITALERT 3000 MONITORING SYSTEM2Cleared 510(K)
- K921526DATASCOPE PASSPORT MONITOR WITH CO22Cleared 510(K)
- K920622RASCAL II2Cleared 510(K)
- K920590OHMEDA MODEL 5250 RGM MONITOR2Cleared 510(K)
- K911970NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE2Cleared 510(K)
- K914337GAS SAMPLING INTERFACES2Cleared 510(K)
- K915228DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL2Cleared 510(K)
- K911193OHMEDA MODEL 4700 OXICAP2Cleared 510(K)
- K911737MEDICAL ASSEMBLIES MASS SPECT MONIT LINE/CONNECT2Cleared 510(K)
- K904863MGA-IR SIDESTREAM PCO2 MODULE2Cleared 510(K)
- K904789SERIES 7000 CARBON DIOXIDE MODULE2Cleared 510(K)
- K910509PATIENT GAS SAMPLING LINE FOR OHMEDA 60002Cleared 510(K)
- K910106DATASCOPE MULTINEX ID MONITOR2Cleared 510(K)
- K910019NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON2Cleared 510(K)
- K905775SIEMENS ETCO2 CARTRIDGE2Cleared 510(K)
- K903200MINICAP III CO2 DETECTOR2Cleared 510(K)
- K896652CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR2Cleared 510(K)
- K901861BIOCHEM 9100 MULTIGAS MONITOR2Cleared 510(K)
- K901132SARA SATCAP2Cleared 510(K)
- K900291MASS SPECTROMETRY MONITORING LINES AND CONNECTORS2Cleared 510(K)
- K900979GAS SAMPLING NASAL CANNULA2Cleared 510(K)
- K896737TYPE 9292 INTERFACE CAPNOGRAPH2Cleared 510(K)
- K895001TYPE EXPIRED CO2 9270, CAPNOGRAPH2Cleared 510(K)
- K896030HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI022Cleared 510(K)
- K894691MODEL AO-800PA CO2 MODULE2Cleared 510(K)
- K895780OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER2Cleared 510(K)
- K894350SALTER LABS MODEL #4009 SAMPLE LINES2Cleared 510(K)
- K894429MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTOR2Cleared 510(K)
- K890817OMNI-TRAK (PATIENT MONITOR)2Cleared 510(K)
- K891076CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR2Cleared 510(K)
- K893589MULTI-GAS ANALYZER (MGA)2Cleared 510(K)
- K892406MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA2Cleared 510(K)
- K8940532ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR2Cleared 510(K)
- K890874BIOCHEM 520 BREATH INDICATOR2Cleared 510(K)
- K890112ENGSTROM ELIZA + CO2 ANALYZER2Cleared 510(K)
- K883090MINICAP TM 100 CAPNOMETER2Cleared 510(K)
- K884158THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER2Cleared 510(K)
- K881206CHRONAMED CM1012Cleared 510(K)
- K884080MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR2Cleared 510(K)
- K882885DATEX AIRWAY MONITOR2Cleared 510(K)
- K882748NORMOCAP 200 CAPNOMETER2Cleared 510(K)
- K883950MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER2Cleared 510(K)
- K883821FEF(TM) END-TIDAL CO2 DETECTOR2Cleared 510(K)
- K882661ACUMED 9000 ETCO(2) MONITOR2Cleared 510(K)
- K881002O.R. SARACAP2Cleared 510(K)
- K882172SARACAP AG2Cleared 510(K)
- K881093ICU SARACAP2Cleared 510(K)
- K873396KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 72812Cleared 510(K)
- K873380VITALERT 1000 MONITORING SYSTEM2Cleared 510(K)
- K874724SARA AGIE MONITOR2Cleared 510(K)
- K874754SARA DIGICAP2Cleared 510(K)
- K871828TED MODEL 7602Cleared 510(K)
- K875268TMM MODEL 2500 CAPMONITOR2Cleared 510(K)
- K873856BIOCHEM 9090 CAPNOGRAPH/SAO22Cleared 510(K)
- K873959BIOCHEM 8800 CAPNOMETER2Cleared 510(K)
- K874036MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY2Cleared 510(K)
- K873149NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 12602Cleared 510(K)
- K872760OSCAR(TM) PB255 OXIMETER CAPNOMETER2Cleared 510(K)
- K871253MASSTRON/MARQUEST MT-1000 GAS ANALYZER2Cleared 510(K)
- K870858BADGWELL SAMPLING CATHETER2Cleared 510(K)
- K871133BIOCHEM 8090 CAPNOGRAPH2Cleared 510(K)
- K864199SALTER LABS #4001 ORAL NASAL CO2 SAMPLING CANNULA2Cleared 510(K)
- K864903MOD. 4006 ADU., OXY. DELIVE.-ORAL CO2 SAM. CANNULA2Cleared 510(K)
- K864902MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.2Cleared 510(K)
- K863883MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA2Cleared 510(K)
- K863703SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE2Cleared 510(K)
- K863640MODIFIED GAS SAMPLING KIT2Cleared 510(K)
- K862880SARA RT2Cleared 510(K)
- K862605MODULAR MASS SPECTROMETER (M.S.)2Cleared 510(K)
- K862543DYNEX CO2/2000, CO2 ANALYZER2Cleared 510(K)
- K862559CARBOSTAT, CO2 ANALYZER2Cleared 510(K)
- K861398PRE-CHECK C02 DETECTOR2Cleared 510(K)
- K861213PB 254 IR - SPECTROMETER2Cleared 510(K)
- K860556SERIES 7050 CAPNOGRAPH2Cleared 510(K)
- K853396MULTICAP MULTIGAS CAPNOMETER PB2522Cleared 510(K)
- K852062SARACAP RESPIRATORY MONITOR2Cleared 510(K)
- K852463ANDROS ANALYZERS AIRWAY ADAPTER2Cleared 510(K)
- K851658CAPNOMED2Cleared 510(K)
- K851001SERIES 7000 END TIDAL CO2 MONITORING SYSTEM2Cleared 510(K)
- K850745TRI-MED MODEL 112 MOISTURE TRAP2Cleared 510(K)
- K850747TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR2Cleared 510(K)
- K850746TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI2Cleared 510(K)
- K844010CPNOGARD CAPNOMETER 12502Cleared 510(K)
- K843285TRI-MED 610 CAPNOSTAT GAS ANALYZER2Cleared 510(K)
- K843970MODEL IM1074 END-TIDAL CO2 MODULE2Cleared 510(K)
- K843844CO2 TEST2Cleared 510(K)
- K843599OHMEDA MODEL 5200 CO2 MONITOR2Cleared 510(K)
- K842334LIFE MONITOR I2Cleared 510(K)
- K842978540 CAPNOGRAPH2Cleared 510(K)
- K842325CAPNOMETER2Cleared 510(K)
- K841498C02 MONITOR-OIR-71012Cleared 510(K)
- K840966ANESTHETIC GAS MONITOR SYS2Cleared 510(K)
- K832005JP-2 RESPIRATORY MONITORING SYSTEM2Cleared 510(K)
- K833397TRI-MED 511 INFANT RESPIRATION MONITOR2Cleared 510(K)
- K831447CAPNOMETER W/NEW AIRWAY ADAPTER 47210A2Cleared 510(K)
- K833060MODEL CD-3A-INCLUDING P-61B SENSOR2Cleared 510(K)
- K832767ADVANTAGE #17002Cleared 510(K)
- K831776CAPNOGRAPH2Cleared 510(K)
- K823049ENGSTROM ELIZA CO2 ANALYZER2Cleared 510(K)
- K812643LIFESPAN CO22Cleared 510(K)
- K810927RESPIRATORY INTENSIVE CARE SYSTEM (RICS)2Cleared 510(K)
- K802459SIEMENS-ELEMA AB CO2 MONITOR 1302Cleared 510(K)
- K800869MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA2Cleared 510(K)
- K792155CO 2 METER2Cleared 510(K)
- K791570IL MODEL END TIDAL CO2 ANALYZER2Cleared 510(K)
- K782138MONITOR, BECKMAN LB-3CO22Cleared 510(K)
- K780324CAPNOMETER MODEL 47210A2Cleared 510(K)
- K780107ANALYZER-PLUG-IN, CO2 MODEL M 31042Cleared 510(K)
- K770968MONITOR, PATIENT, MODEL PM-I0N2Cleared 510(K)
- K770721MONITORS, REMOTE, RMS III2Cleared 510(K)
- K770713MONITOR, PATIENT, RESP. CARBON DIOXIDE2Cleared 510(K)
- K770123EXERCISE RESPIRATORY GAS ANALYZER2Cleared 510(K)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase2Product Code
- CCMPlethysmograph, Pressure2Product Code
- JEDAnalyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling3Product Code
- JEFAnalyzer, Gas, Neon, Gaseous-Phase2Product Code
- JEGAnalyzer, Gas, Argon, Gaseous-Phase2Product Code
- JEHPlethysmograph, Volume2Product Code
- JFEValve, Switching (Ploss)1Product Code
- KGKGas, Collecting Vessel1Product Code
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)2Product Code
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)2Product Code
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)2Product Code
- OFZBlood Specimen Collection Kit (Excludes Hiv Testing)1Product Code
- PNVImpedance Measuring Device Utilizing Oscillation Techniques2Product Code
- OGKOrotracheal Intubation Guide Kit2Product Code
- PHZAbnormal Breath Sound Device2Product Code
- QEBVentilatory Electrical Impedance Tomograph2Product Code
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- 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
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- 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
MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K180902
- 510(k) Type
- Traditional
- Applicant
- MediPines Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/11/2019
- Days to Decision
- 280 days
- Submission Type
- Summary