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 |