Sleepio®
FDA 510(k) clearance K233577 · decided 2024-08-05
Clearance details
- K-number
- K233577
- Device name
- Sleepio®
- Applicant
- Big Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-07
- Decision date
- 2024-08-05
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- QVO
- Device class
- 2
- Regulation number
- 882.5801
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Francisco, 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 |
|---|---|---|
| Somryst (K191716) | Pear Therapeutics, Inc. | 2020-03-23 |
Recalls involving this device
No recalls on record reference this clearance.