reSET-O
FDA 510(k) clearance K173681 · decided 2018-12-10
Clearance details
- K-number
- K173681
- Device name
- reSET-O
- Applicant
- Pear Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-12-01
- Decision date
- 2018-12-10
- Days to decision
- 374 days
- Clearance type
- Traditional
- Product code
- PWE
- Device class
- 2
- Regulation number
- 882.5801
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Boston, MA, 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 |
|---|---|---|
| reSet (DEN160018) | Pear Therapeutics, Inc. | 2017-09-14 |
Recalls involving this device
No recalls on record reference this clearance.