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510(k) K211463

Device
Regulora
Applicant
MetaMe Health, Inc.
510(k) number
K211463
Product code
QMY  
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-24
Date received
2021-05-11
Regulation
876.5960
Classification name
Computerized Behavioral Therapy Device For Treating Symptoms
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tim Rudolphi
Address
222 W. Merchandise Mart Plz. - Suite 1230 Chicago IL US 60654 60654

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QMY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K211372Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)Mahana Therapeutics, Inc.2021-06-02
DEN200029ParallelMahana Therapeutics, Inc.2020-11-25

Legacy Summary#

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FDA Review#

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