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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Sleep Assessment
510(k) Number K251574
Device Name Sleep Watch
Applicant
Ambulatory Monitoring, Inc.
731 Saw Mill River Rd.
Ardsley,  NY  10502
Applicant Contact Paul Chen
Correspondent
Ambulatory Monitoring, Inc.
731 Saw Mill River Rd.
Ardsley,  NY  10502
Correspondent Contact Paul Chen
Regulation Number882.5050
Classification Product Code
LEL  
Date Received05/22/2025
Decision Date 07/31/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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