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Pulse Oximeter For Low-Acuity Settings

Page Type
Product Code
Definition
Pulse oximeter intended for low-acuity settings.
Physical State
Used to transmit light at known wavelengths(s) through blood using a light emitting diode(s) and sensor.
Technical Method
Transmit light at a known wavelength(s) through blood to measure photoplethysmographic data based on the amount of reflected or scattered light.
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

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).

Pulse Oximeter For Low-Acuity Settings

Page Type
Product Code
Definition
Pulse oximeter intended for low-acuity settings.
Physical State
Used to transmit light at known wavelengths(s) through blood using a light emitting diode(s) and sensor.
Technical Method
Transmit light at a known wavelength(s) through blood to measure photoplethysmographic data based on the amount of reflected or scattered light.
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

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).