510(k) K214115
K214115 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "MightySat -OTC". The FDA issued a decision of Substantially Equivalent on January 31, 2024. The device falls under product code OLK (Pulse Oximeter For Over-The-Counter Use), a Class II device regulated under 21 CFR 870.2700. Masimo Corporation has at least 10 other 510(k) clearances on record.
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