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
- K102229PULMOTRACK 2020 SYSTEM2Cleared 510(K)
- K090863PERSONAL WHEEZOMETER2Cleared 510(K)
- K071955WIM-PC, MODEL 10102Cleared 510(K)
- K012387STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM2Cleared 510(K)
- K980878PULMOTRACK,MODEL 10102Cleared 510(K)
- K974200ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM2Cleared 510(K)
- K955432CPX, CCM, CATH WITH 15% CO22Cleared 510(K)
- K923209MEDGRAPHICS EXERCISE CONSULT2Cleared 510(K)
- K911143PB100 DIAGNOSTIC SPIROMETER2Cleared 510(K)
- K896345EXERCISE EVALUATION SYSTEM 20102Cleared 510(K)
- K880550BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS2Cleared 510(K)
- K874902SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY2Cleared 510(K)
- K871711MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM2Cleared 510(K)
- K864911EXERSYSTEM(TM) MMC 50002Cleared 510(K)
- K864885SPIROVISION2Cleared 510(K)
- K863953SPIROMETRICS MODEL 2500 FLOWMATE(TM)2Cleared 510(K)
- K861929PULMONARY FUNCTION TEST LABORATORY, SYSTEM 10702Cleared 510(K)
- K853190SUPERSPIRO2Cleared 510(K)
- K851706UNIVERSAL COMPUTER INTERFACE SYSTEM2Cleared 510(K)
- K842782PHYSIOLOGICAL ANALYZER CM-7102Cleared 510(K)
- K831586CM-VII PHYSIOLOGIC ANALYZER2Cleared 510(K)
- K820035CDX 2002Cleared 510(K)
- K801496PULMONARY LAB AUTOMATION SYSTEM2Cleared 510(K)
- K801495CARDIO-PULMONARY EXERCISE STRESS SYSTEM2Cleared 510(K)
- K791229CYBER DX 1002Cleared 510(K)
- K771371SCREENING COMPUTEO SC-202Cleared 510(K)
- 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
- 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
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- 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
SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY
- Page Type
- Cleared 510(K)
- 510(k) Number
- K874902
- 510(k) Type
- Traditional
- Applicant
- GOMI MEDICAL INSTRUMENTS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/7/1988
- Days to Decision
- 189 days