OLK · Pulse Oximeter For Over-The-Counter Use
Cardiovascular · 21 CFR 870.2700 · Class 2
Overview
| Product Code | OLK |
|---|---|
| Device Name | Pulse Oximeter For Over-The-Counter Use |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. | Nov 13, 2024 | SESE |
| K214115 | MightySat -OTC | Masimo Corporation | Jan 31, 2024 | SESE |
Top Applicants
- Masimo Corporation — 1 clearance
- Nonin Medical, Inc. — 1 clearance
