510(k) DEN160018
- Device
- reSet
- Applicant
- Pear Therapeutics, Inc.
- 510(k) number
- DEN160018
- Product code
- PWE
- Decision
- Unknown (DENG)
- Decision date
- 2017-09-14
- Date received
- 2016-05-16
- Regulation
- 882.5801
- Classification name
- Computerized Behavioral Therapy Device For Substance Use Disorders
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- NANDINI MURTHY
- Address
- 745 Atlantic Ave. Boston MA US 02111 02111
FDA Registration Numbers#
- 3033280591
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PWE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K173681 | reSET-O | Pear Therapeutics, Inc. | 2018-12-10 |