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
- K040917PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B2Cleared 510(K)
- K994188MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO52Cleared 510(K)
- K962648OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR2Cleared 510(K)
- K931439OHMEDA MODEL 5330 ANESTHETIC MONITOR2Cleared 510(K)
- K926451DATASCOPE MULTINEX II2Cleared 510(K)
- K923433AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE2Cleared 510(K)
- K923276CAPNOMAC ULTIMA ANESTHESIA MONITOR2Cleared 510(K)
- K922876AS/3 COP MODULE2Cleared 510(K)
- K930303DATASCOPE MULTINEX ID PLUS2Cleared 510(K)
- K914295ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED2Cleared 510(K)
- K911644NGM FRAME2Cleared 510(K)
- K911647NGM GAS MODULE2Cleared 510(K)
- K903104CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR2Cleared 510(K)
- K902021RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR2Cleared 510(K)
- K892854ANESTHETIC AGENT MONITOR2Cleared 510(K)
- K892646BIOCHEM 8100 ANESTHETIC AGENT MONITOR2Cleared 510(K)
- K890606OHMEDA 5330 AGENT MONITOR2Cleared 510(K)
- K883532ICOR AGENT MONITOR2Cleared 510(K)
- K881264PERMA PURE NAFION TUBE DRYER-MODEL ME2Cleared 510(K)
- K863248PB GRAPHICS PRINTER AND PB VIDEO DISPLAY2Cleared 510(K)
- K861397OHMEDA 5300 ANESTHETIC AGENT MONITOR2Cleared 510(K)
- K861474PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT2Cleared 510(K)
- 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
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- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
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- UnknownReview Panel
NGM FRAME
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K911644
- 510(k) Type
- Traditional
- Applicant
- DATEX DIVISION INSTRUMENTARIUM CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/4/1992
- Days to Decision
- 324 days