The following data is part of a premarket notification filed by Pear Therapeutics, Inc. with the FDA for Reset-o.
Device ID | K173681 |
510k Number | K173681 |
Device Name: | ReSET-O |
Classification | Computerized Behavioral Therapy Device For Psychiatric Disorders |
Applicant | Pear Therapeutics, Inc. 745 Atlantic Ave. Boston, MA 02111 |
Contact | Yuri Maricich |
Correspondent | Nandini Murthy Pear Therapeutics, Inc. 745 Atlantic Ave. Boston, MA 02111 |
Product Code | PWE |
CFR Regulation Number | 882.5801 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-01 |
Decision Date | 2018-12-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10851580008125 | K173681 | 000 |
10196439000036 | K173681 | 000 |
10851580008163 | K173681 | 000 |
10851580008170 | K173681 | 000 |
10851580008187 | K173681 | 000 |
10851580008224 | K173681 | 000 |
10851580008231 | K173681 | 000 |
10851580008248 | K173681 | 000 |
10851580008057 | K173681 | 000 |
10851580008064 | K173681 | 000 |
10851580008101 | K173681 | 000 |
10851580008118 | K173681 | 000 |
10196439000029 | K173681 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() RESET-O 87925200 not registered Live/Pending |
Pear Therapeutics, Inc. 2018-05-17 |
![]() RESET-O 87925189 not registered Live/Pending |
Pear Therapeutics, Inc. 2018-05-17 |
![]() RESET-O 87635226 5740689 Live/Registered |
Pear Therapeutics, Inc. 2017-10-05 |