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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computerized Behavioral Therapy Device For Treating Symptoms
510(k) Number K211372
Device Name Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
Applicant
Mahana Therapeutics, Inc.
One Market, Spear Tower 36th Floor
San Francisco,  CA  94105
Applicant Contact Jean-Noel Courvoisier
Correspondent
Mahana Therapeutics, Inc.
One Market, Spear Tower 36th Floor
San Francisco,  CA  94105
Correspondent Contact Jean-Noel Courvoisier
Regulation Number876.5960
Classification Product Code
QMY  
Date Received05/04/2021
Decision Date 06/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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