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
- K200076Breezing Med2Cleared 510(K)
- K190561NICU V'022Cleared 510(K)
- K110810ANASCIENT BREATH MONITOR2Cleared 510(K)
- K093080METAPHOR METABOLIC MONITOR2Cleared 510(K)
- K071533FITMATE SERIES2Cleared 510(K)
- K070858EXPRESS SERIES2Cleared 510(K)
- K061731MEDGRAPHICS ULTIMA SYSTEM2Cleared 510(K)
- K021490REEVUE INDIRECT CALORIMETER, MODEL#81002Cleared 510(K)
- K021605MEDGEM2Cleared 510(K)
- K010577BODYGEM, MODEL HB2112Cleared 510(K)
- K954731OXYLOG 22Cleared 510(K)
- K9249787250 METABOLIC MONITOR2Cleared 510(K)
- K921565CARDIOPULMONARY METABOLIC MEASUEMENT CART2Cleared 510(K)
- K931422DELTATRAC(TM) II METABOLIC MONITOR2Cleared 510(K)
- K922660PHYSIO-DYNE EASI - LAB2Cleared 510(K)
- K912906MEDGRAPHICS PF/DX2Cleared 510(K)
- K895791OXYMAX2Cleared 510(K)
- K895935ICOR CMU Q PLUS2Cleared 510(K)
- K895586VVR/Q CALORIMETER2Cleared 510(K)
- K874663MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM2Cleared 510(K)
- K864603DELTATRAC(TM) METABOLIC MONITOR2Cleared 510(K)
- K864852VISTA INTERFACE SYSTEM2Cleared 510(K)
- K854927ICOR CALARIC MEASUREMENT UNIT (CMU)2Cleared 510(K)
- K853434ERGO-PNEUMOTEST2Cleared 510(K)
- K833714RESPIRATORY ASSESSMENT SYSTEM2Cleared 510(K)
- K831780METABOLIC EXERCISE TESTING SYSTEM2Cleared 510(K)
- K823695CPM METABOLIC MONITOR2Cleared 510(K)
- K822710METABOLIC MEASUREMENT CART2Cleared 510(K)
- K821344ENGSTROM METABOLIC COMPUTER2Cleared 510(K)
- K820905BECKMAN MMC II METABOLIC MEAS. CART2Cleared 510(K)
- K820475MGC/LITTON 23002Cleared 510(K)
- K802417AB O2 CONSUMPTION CALCULATOR 9802Cleared 510(K)
- K801852MRM-2 OXYGEN CONSUMPTION MONITOR2Cleared 510(K)
- 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
- 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
ENGSTROM METABOLIC COMPUTER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K821344
- 510(k) Type
- Traditional
- Applicant
- LKB INSTRUMENTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/28/1982
- Days to Decision
- 23 days