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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 insomnia
510(k) Number K191716
Device Name Somryst
Applicant
Pear Therapeutics, Inc.
201 Mission St. #1450
San Francisco,  CA  94105
Applicant Contact David Amor
Correspondent
Pear Therapeutics, Inc.
201 Mission St. #1450
San Francisco,  CA  94105
Correspondent Contact Yuri Maricich
Regulation Number882.5801
Classification Product Code
QVO  
Date Received06/26/2019
Decision Date 03/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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