Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)— 510(k) K211372

Name: FDA 510(k) clearance K211372
Creator: U.S. Food and Drug Administration
Published: 2021-06-02

Substantially Equivalent

Mahana Therapeutics, Inc.

FDA 510(k) clearance K211372 for Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS), Substantially Equivalent on 2021-06-02. Applicant: Mahana Therapeutics, Inc..

Clearance details

Applicant: Mahana Therapeutics, Inc.
Product code: Code QMY
Advisory panel: Gastroenterology, Urology
Date received: 2021-05-04
Decision date: 2021-06-02
Decision: Substantially Equivalent
Clearance type: Special
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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