Parallel

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 ID: DEN200029
• Device Name: Parallel
• Classification: Computerized Behavioral Therapy Device For Treating Symptoms
• Applicant: Mahana Therapeutics, Inc. 230 California Street, Suite 302 San Francisco, CA 94111
• Contact: Jean-noel Courvoisier
• Product Code: QMY
• CFR Regulation Number: 876.5960 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device 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 Board: Gastroenterology/Urology
• Classification Advisory: Gastroenterology/Urology
• Type: Direct
• Date Received: 2020-04-30
• Decision Date: 2020-11-25
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860006172008	DEN200029	000