Name: Predicase
Price: 199 USD

K-number	K211372
Device name	Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
Applicant	Mahana Therapeutics, Inc.
Product code	QMY
Device class	Class II
Decision date	Jun 2, 2021
Decision	Substantially Equivalent
Regulation	876.5960

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.