Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- 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
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Pulse Oximeter For Over-The-Counter Use
- Page Type
- Product Code
- Definition
- Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring
- Physical State
- Used to transmit light at known wavelengths(s) through blood using a light emitting diode(s) and photodetector.
- Technical Method
- The device transmits radiation at a known wavelength(s) through blood and measures the blood oxygen saturation based on the amount of reflected or scattered radiation.
- Target Area
- Peripheral circulatory pulse.
- Regulation Medical Specialty
- Cardiovascular
- Review Panel
- Anesthesiology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 870.2700
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- 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 § 870.2700 Oximeter
§ 870.2700 Oximeter.
(a) Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
(b) Classification. Class II (performance standards).