FDA 510(k), K173681, reSET-O

510(K) Number: K173681
Device Name: reSET-O
Manufacturer: Yuri Maricich
Device Classification Name: Computerized Behavioral Therapy Device For Substance Use Disorders
Regulation Number: PWE
Classification Product Code: KXA
Date Received: 12/01/2017
Decision Date: 12/10/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology

Total pages: 2157
Fully redacted pages: 1903
Content pages: 254