Nonin OTC Pulse Oximeter Model 3250
FDA 510(k) clearance K211498 · decided 2024-11-13
Clearance details
- K-number
- K211498
- Device name
- Nonin OTC Pulse Oximeter Model 3250
- Applicant
- Nonin Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-05-14
- Decision date
- 2024-11-13
- Days to decision
- 1279 days
- Clearance type
- Traditional
- Product code
- OLK
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, 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 |
|---|---|---|
| MightySat -OTC (K214115) | Masimo Corporation | 2024-01-31 |
Recalls involving this device
No recalls on record reference this clearance.