21 CFR 870.2700 — Oximeter
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2700
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DQA | Oximeter | 2 | 723 | |
| MUD | Oximeter, Tissue Saturation | 2 | 73 | 3rd Party |
| NLF | Oximeter, Reprocessed | 2 | 27 | 3rd Party |
| NMD | Oximeter, Tissue Saturation, Reprocessed | 2 | 2 | 3rd Party |
| OCH | Oximeter, Infrared, Sporting, Aviation | 2 | 0 | |
| OLK | Pulse Oximeter For Over-The-Counter Use | 2 | 2 | |
| PGJ | Oximeter, Wellness | 2 | 0 | |
| QEM | Cerebral Oximeter | 2 | 1 | SaMD |
