MightySat -OTC
FDA 510(k) clearance K214115 · decided 2024-01-31
Clearance details
- K-number
- K214115
- Device name
- MightySat -OTC
- Applicant
- Masimo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-12-30
- Decision date
- 2024-01-31
- Days to decision
- 762 days
- Clearance type
- Traditional
- Product code
- OLK
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Nonin OTC Pulse Oximeter Model 3250 (K211498) | Nonin Medical, Inc. | 2024-11-13 |
Recalls involving this device
No recalls on record reference this clearance.