510(k) K173681
K173681 is an FDA 510(k) premarket notification submitted by Pear Therapeutics, Inc. for the device "reSET-O". The FDA issued a decision of Substantially Equivalent on Dec 10, 2018. The device falls under product code PWE (Computerized Behavioral Therapy Device For Substance Use Disorders), a Class II device regulated under 21 CFR 882.5801. Pear Therapeutics, Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 10, 2018
- Date Received
- Dec 1, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Computerized Behavioral Therapy Device For Substance Use Disorders
- Device Class
- Class II
- Regulation Number
- 882.5801
- Review Panel
- NE
- Submission Type
- 510(k)
The device is intended to provide cognitive behavioral therapy to treat substance use disorder.