Last synced on 12 July 2024 at 11:04 pm

Cerebral Oximeter

Page Type
Product Code
Definition
Oximeter to measure cerebral tissue saturation
Physical State
Light radiation transmitter and receiver with associated analytical hardware and software to process the signal
Technical Method
Transmits light radiation at known wavelength(s) through blood to measure oxygen saturation based on the amount of reflected or scattered radiation
Target Area
Head, Skull, Brain
Regulation Medical Specialty
Cardiovascular
Review Panel
Neurology
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).

Cerebral Oximeter

Page Type
Product Code
Definition
Oximeter to measure cerebral tissue saturation
Physical State
Light radiation transmitter and receiver with associated analytical hardware and software to process the signal
Technical Method
Transmits light radiation at known wavelength(s) through blood to measure oxygen saturation based on the amount of reflected or scattered radiation
Target Area
Head, Skull, Brain
Regulation Medical Specialty
Cardiovascular
Review Panel
Neurology
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).