OLK — Pulse Oximeter For Over-The-Counter Use Class II
FDA product code OLK covers "Pulse Oximeter For Over-The-Counter Use", a Class II medical device regulated under 21 CFR 870.2700. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OLK
- Device Class
- Class II
- Regulation Number
- 870.2700
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring