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FDA 510(k) Applications for Medical Device Product Code "QMY"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K211372
Mahana Therapeutics Inc.
Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
06/02/2021
DEN200029
Mahana Therapeutics, Inc.
Parallel
11/25/2020
K211463
metaMe Health, Inc.
Regulora
11/24/2021
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