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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computerized Behavioral Therapy Device For Treating Symptoms
510(k) Number K211463
Device Name Regulora
Applicant
Metame Health, Inc.
222 W. Merchandise Mart Plz. - Suite 1230
Chicago,  IL  60654
Applicant Contact Tim Rudolphi
Correspondent
Metame Health, Inc.
222 W. Merchandise Mart Plz. - Suite 1230
Chicago,  IL  60654
Correspondent Contact Nandini Murthy
Regulation Number876.5960
Classification Product Code
QMY  
Date Received05/11/2021
Decision Date 11/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT04133519
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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