Masimo Stork
FDA 510(k) clearance K234021 · decided 2024-05-03
Clearance details
- K-number
- K234021
- Device name
- Masimo Stork
- Applicant
- Masimo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-12-20
- Decision date
- 2024-05-03
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- QYU
- Device class
- 2
- Regulation number
- 870.2705
- 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.
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|---|---|---|
| Dream Sock (DEN220091) | Owlet Babycare, Inc. | 2023-11-08 |
Recalls involving this device
No recalls on record reference this clearance.