510(k) K214115
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2024
- Date Received
- December 30, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pulse Oximeter For Over-The-Counter Use
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type
Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring