Last synced on 27 January 2023 at 11:04 pm

Oximeter, Ear

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.2710
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.2710 Ear oximeter

§ 870.2710 Ear oximeter.

(a) Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

(b) Classification. Class II (performance standards).

Oximeter, Ear

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.2710
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.2710 Ear oximeter

§ 870.2710 Ear oximeter.

(a) Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

(b) Classification. Class II (performance standards).