The following data is part of a premarket notification filed by Pear Therapeutics, Inc. with the FDA for Somryst.
| Device ID | K191716 |
| 510k Number | K191716 |
| Device Name: | Somryst |
| Classification | Computerized Behavioral Therapy Device For Psychiatric Disorders |
| Applicant | Pear Therapeutics, Inc. 201 Mission St. #1450 San Francisco, CA 94105 |
| Contact | David Amor |
| Correspondent | Yuri Maricich Pear Therapeutics, Inc. 201 Mission St. #1450 San Francisco, CA 94105 |
| Product Code | PWE |
| CFR Regulation Number | 882.5801 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-26 |
| Decision Date | 2020-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851580008255 | K191716 | 000 |
| 15694311112112 | K191716 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SOMRYST 88324208 not registered Live/Pending |
Pear Therapeutics, Inc. 2019-03-04 |
![]() SOMRYST 88324178 not registered Live/Pending |
Pear Therapeutics, Inc. 2019-03-04 |