Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application For Irritable Bowel Syndrome (IBS)

Computerized Behavioral Therapy Device For Treating Symptoms

Mahana Therapeutics Inc.

The following data is part of a premarket notification filed by Mahana Therapeutics Inc. with the FDA for Mahana Parallel Digital Cognitive Behavioral Therapy (cbt) Mobile Application For Irritable Bowel Syndrome (ibs).

Pre-market Notification Details

Device IDK211372
510k NumberK211372
Device Name:Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application For Irritable Bowel Syndrome (IBS)
ClassificationComputerized Behavioral Therapy Device For Treating Symptoms
Applicant Mahana Therapeutics Inc. One Market, Spear Tower 36th Floor San Francisco,  CA  94105
ContactJean-noel Courvoisier
CorrespondentJean-noel Courvoisier
Mahana Therapeutics Inc. One Market, Spear Tower 36th Floor San Francisco,  CA  94105
Product CodeQMY  
CFR Regulation Number876.5960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-04
Decision Date2021-06-02

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