Last synced on 27 January 2023 at 11:04 pm

Oximeter, Reprocessed

Page Type
Product Code
Definition
same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
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).

Oximeter, Reprocessed

Page Type
Product Code
Definition
same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
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).