Computerized Behavioral Therapy Device For Treating Symptoms

Mahana Therapeutics, Inc.

The following data is part of a De Novo classification by Mahana Therapeutics, Inc. with the FDA for Parallel.

Pre-market Notification Details

DeNovo IDDEN200029
Device Name:Parallel
ClassificationComputerized Behavioral Therapy Device For Treating Symptoms
Applicant Mahana Therapeutics, Inc. 230 California Street, Suite 302 San Francisco,  CA  94111
ContactJean-noel Courvoisier
Product CodeQMY  
CFR Regulation Number876.5960 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
Date Received2020-04-30
Decision Date2020-11-25
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
00860006172008 DEN200029 000

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