Somryst
FDA 510(k) clearance K191716 · decided 2020-03-23
Clearance details
- K-number
- K191716
- Device name
- Somryst
- Applicant
- Pear Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-06-26
- Decision date
- 2020-03-23
- Days to decision
- 271 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 |
|---|---|---|
| Sleepio® (K233577) | Big Health, Inc. | 2024-08-05 |
Recalls involving this device
No recalls on record reference this clearance.