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
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase2Product Code
- K251245OxyMinder Pro (10310)2Cleared 510(K)
- K250002Smart Check O2 (MA0236)2Cleared 510(K)
- K221734Maxtec MaxO2 ME+p2Cleared 510(K)
- K213933Percent Oxygen Sensors2Cleared 510(K)
- K213948OxyMinder2Cleared 510(K)
- K173807Accu O2 Oxygen Analyzer2Cleared 510(K)
- K153659MaxO2ME2Cleared 510(K)
- K123195CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES2Cleared 510(K)
- K122290ENVITEC MYSIGN O OXYGEN MEASURING DEVICE2Cleared 510(K)
- K112402ULTRAMAXO2 OXYGEN ANALYER2Cleared 510(K)
- K082655ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M1062Cleared 510(K)
- K072469DIGIFLO CONCENTRATOR ANALYZER2Cleared 510(K)
- K063096PRECISION OXYGEN MONITOR2Cleared 510(K)
- K063488MAXO2 CU2Cleared 510(K)
- K053407OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M2Cleared 510(K)
- K051092DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC2Cleared 510(K)
- K041773OXYGEN MEDICELS, CITICELS2Cleared 510(K)
- K040484MAXO2+, MODEL A AND AE2Cleared 510(K)
- K024228RX300 OXYGEN ANALYZER2Cleared 510(K)
- K024155MX 300 OXYGEN MONITOR2Cleared 510(K)
- K023565OXICHECK2Cleared 510(K)
- K010318PRIMA OXYGEN MONITOR2Cleared 510(K)
- K002382'ALL 2000' % OXYGEN ANALYZER2Cleared 510(K)
- K010382100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I2Cleared 510(K)
- K002384M-XX OXYGEN SENSORS2Cleared 510(K)
- K000700SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR2Cleared 510(K)
- K001095OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO1302Cleared 510(K)
- K990403TED 200T7 OXYGEN MONITOR2Cleared 510(K)
- K990457TED 60T OXYGEN ANALYZER2Cleared 510(K)
- K991884SIEMENS FIO2 SENSOR2Cleared 510(K)
- K984295INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)2Cleared 510(K)
- K983500PRO2 CHECK OXYGEN INDICATOR2Cleared 510(K)
- K982619HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A022Cleared 510(K)
- K971084MODEL 02 OXYGEN ANALYZER2Cleared 510(K)
- K973545VACU*MED GOLD EDITION OXYGEN GAS ANALYZER2Cleared 510(K)
- K972992CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS2Cleared 510(K)
- K973282HANDI OXYGEN ANALYZER2Cleared 510(K)
- K963177TED 1912Cleared 510(K)
- K963415VENTREX OXYGEN SENSOR2Cleared 510(K)
- K943824GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION2Cleared 510(K)
- K961644MINIOX 3000 OXYGEN MONITOR2Cleared 510(K)
- K951038OXYCHECK OXYGEN MONITOR2Cleared 510(K)
- K952736PERCENT OXYGEN SENSOR2Cleared 510(K)
- K953351SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS2Cleared 510(K)
- K941793OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)2Cleared 510(K)
- K944120FI02 SENSING MODULE2Cleared 510(K)
- K942593OXYCHEK OXYGEN ANALYZER2Cleared 510(K)
- K944654OXYGEN CONCENTRATION INDICATOR2Cleared 510(K)
- K935364MINIOX 1000 OXYGEN CONCENTRATION INDICATOR2Cleared 510(K)
- K922438PRO2 OXYGEN ANALYZER2Cleared 510(K)
- K922738VTI OXYGEN ANALYZER2Cleared 510(K)
- K920338COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR2Cleared 510(K)
- K913392OXYGEN SENSING DEVICE, MODIFICATION2Cleared 510(K)
- K910381BIOCHEM TEMPERATURE/ FIO2 MODULE2Cleared 510(K)
- K911344CERION HAND HELD OXYGEN ANALYZER2Cleared 510(K)
- K896359AG-820PA FI02 MODULE2Cleared 510(K)
- K896427SPACELABS' MODEL 90514, MULTIGAS ANALYZER2Cleared 510(K)
- K890058VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM2Cleared 510(K)
- K894918HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.2Cleared 510(K)
- K891674NEONATAL ENVIRONMENTAL MONITOR, MODEL 2752Cleared 510(K)
- K890144OXITRON OXYGEN SENSOR2Cleared 510(K)
- K890958OXITRON OXYGEN ANALYZER2Cleared 510(K)
- K882352MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT.2Cleared 510(K)
- K880378LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-0012Cleared 510(K)
- K883254MULTINEX MONITOR (MODIFICATION)2Cleared 510(K)
- K882743OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)2Cleared 510(K)
- K881663OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES2Cleared 510(K)
- K881473SL01 OXYGEN ANALYZER2Cleared 510(K)
- K881472SL02 OXYGEN ANALYZER2Cleared 510(K)
- K875183LC OXYGEN ANALYZER2Cleared 510(K)
- K880448CERION OXY THRESHOLD ALARM2Cleared 510(K)
- K873068OXYGEN ANALYZER MODEL 800 SERIES2Cleared 510(K)
- K872001MODEL TPC-1A OXYGEN ANALYZER2Cleared 510(K)
- K871337M-2 OXYGEN/TEMPERATURE MONITOR2Cleared 510(K)
- K863158MODEL T-1 OXYGEN ANALYZER2Cleared 510(K)
- K863806MODEL A-1 OXYGEN ANALYZER2Cleared 510(K)
- K862113NO. 100352 GALVANIC OXYGEN SENSOR2Cleared 510(K)
- K861625SERVO GAS MONITOR 1202Cleared 510(K)
- K854799EMERSON MODEL 3MV-OAA ALARM MODULE2Cleared 510(K)
- K854599VICKERS MEDICAL MODEL 273 OXYGEN MONITOR2Cleared 510(K)
- K852823DMA OXYGEN MONITOR2Cleared 510(K)
- K853082OHMEDA 5120 OXYGEN MONITOR2Cleared 510(K)
- K852275VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR2Cleared 510(K)
- K843847O2 TEST2Cleared 510(K)
- K840645ENGSTROM ELIZA DUO CO2 & O2 ANALYZ2Cleared 510(K)
- K840565MONITOR 5590- ANALYZER 5595EC2Cleared 510(K)
- K840392NOVOX OXYGEN ANALYZER 4002Cleared 510(K)
- K840361OXYGEN ANALYZER 2002Cleared 510(K)
- K833496OXYGEN MONITOR/CONTROLLER2Cleared 510(K)
- K833995MINI OX II2Cleared 510(K)
- K831522BIO-TEK PERCENT OXYGEN MONITOR 742222Cleared 510(K)
- K831238OXYMED2Cleared 510(K)
- K830446OXYGEN MONITOR OHIO 51002Cleared 510(K)
- K830124OPTION A02 MODEL 15202A2Cleared 510(K)
- K823449RESPIRATORY GAS ANALYZER2Cleared 510(K)
- K823374OXYGEN MONITOR IL 4082Cleared 510(K)
- K823231YSI #2600 MULTI-CHANNEL DUAL-DISPLAY2Cleared 510(K)
- K823232YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP2Cleared 510(K)
- K822608MK 808 SERIES NASAL OXYGEN SAMPLER2Cleared 510(K)
- K821392MODEL TPC-1 OXYGEN ANALYZER2Cleared 510(K)
- K813198RESPIRATOR MONITOR2Cleared 510(K)
- K812854VENTRONICS #5590 ECII OXYGEN MONITOR2Cleared 510(K)
- K812855VENTRONICS #5595 ECII OXYGEN ANALYZER2Cleared 510(K)
- K812587MONO 2 OXYGEN MONITOR2Cleared 510(K)
- K812040OXYGEN MONITOR 140/1412Cleared 510(K)
- K811702MODEL 381 HOME OXYGEN SENTRY2Cleared 510(K)
- K810571NEOCARE OXYGEN MONITOR2Cleared 510(K)
- K802762NORMOCAP CR-102, RECORDER UNIT2Cleared 510(K)
- K801607MOM 22Cleared 510(K)
- K801083NORMCAP CD-102, CARBON DIOXIDE ANALYZER2Cleared 510(K)
- K792356OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR2Cleared 510(K)
- K791199ANESTHESIA OXYGEN ANALYZER MODEL 1012Cleared 510(K)
- K790785MODEL M25RL, (CRC) OXYGEN ANALYZER2Cleared 510(K)
- K790784MODEL M25R, OXYGEN ANALYZER2Cleared 510(K)
- K782062ANALYZER, OXYGEN MODEL M25RA & M25RAD2Cleared 510(K)
- K782114MONITOR, OXYCHEK OXYGEN2Cleared 510(K)
- K781209MONITOR, OXYGEN, MODEL 3000A2Cleared 510(K)
- K780448TRANSPORTABLE OXYGEN PURITY ANALYZER2Cleared 510(K)
- K771028ANALYZER, OXYGEN, MODEL OM-922Cleared 510(K)
- K770207MONITOR, OXYGEN, MODEL 78216C2Cleared 510(K)
- K760338MONITOR, RESP. OXYGEN (TOP)2Cleared 510(K)
- 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 B—Neurological Diagnostic DevicesCFR Sub-Part
- 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
PRIMA OXYGEN MONITOR
- Page Type
- Cleared 510(K)
- 510(k) Number
- K010318
- 510(k) Type
- Traditional
- Applicant
- PENLON LTD.
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/23/2001
- Days to Decision
- 171 days
- Submission Type
- Summary