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510(k) K173681

reSET-O by Pear Therapeutics, Inc. — Product Code PWE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 10, 2018
Date Received: December 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

The device is intended to provide cognitive behavioral therapy to treat substance use disorder.