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
- 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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- HematologyReview Panel
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Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
- Page Type
- Product Code
- Definition
- A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
- Regulation Medical Specialty
- Anesthesiology
- Review Panel
- Anesthesiology
- Submission Type
- PMA
- Device Classification
- Class 3
- Regulation Number
- 868.1120
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 868.1120 Indwelling blood oxyhemoglobin concentration analyzer
§ 868.1120 Indwelling blood oxyhemoglobin concentration analyzer.
(a) Identification. An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen-carrying capacity of hemoglobin in blood to aid in determining the patient's physiological status.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 52 FR 22577, June 12, 1987; 69 FR 34920, June 23, 2004]