FDA Product Code
FDA Product Code PWE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5801
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K173681 | reSET-O | Pear Therapeutics, Inc. | 2018-12-10 | Traditional | PDF ↗ |
| DEN160018 | reSet | Pear Therapeutics, Inc. | 2017-09-14 | Direct | — |
Product code PWE · Class II · Neurology. Data: openFDA.