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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilatory effort recorder
510(k) Number K160499
Device Name Apnea Risk Evaluation System (ARES), Model 620
Watermark Medical
1641 Worthington Road, Suite 320
West Palm Beach,  FL  33409
Applicant Contact Frank Katarow
Michael Leigh
19019 W. Coffee Road
New Berlin,  WI  53146
Correspondent Contact Michael Leigh
Regulation Number868.2375
Classification Product Code
Date Received02/23/2016
Decision Date 04/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No