510(k) K173681
- Device
- ReSET-O
- Applicant
- Pear Therapeutics, Inc.
- 510(k) number
- K173681
- Product code
- PWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-12-10
- Date received
- 2017-12-01
- Regulation
- 882.5801
- Classification name
- Computerized Behavioral Therapy Device For Psychiatric Disorders
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Yuri Maricich
- Address
- 745 Atlantic Ave. Boston MA US 02111 02111
FDA Registration Numbers#
- 3033280591
Source Documents#
Other 510(k) Records For Product Code PWE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN160018 | reSet | Pear Therapeutics, Inc. | 2017-09-14 |
Legacy Summary#
summary
FDA Review#
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