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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 K233577
Device Name Sleepio®
Applicant
Big Health, Inc.
461 Bush St.
Suite 200
San Francisco,  CA  94108
Applicant Contact Reuben Lawson
Correspondent
Big Health, Inc.
461 Bush St.
Suite 200
San Francisco,  CA  94108
Correspondent Contact Reuben Lawson
Regulation Number882.5801
Classification Product Code
QVO  
Date Received11/07/2023
Decision Date 08/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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