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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 K153070
Device Name Watch-PAT200U
Applicant
Itamar Medical , Ltd.
9 Halamish St.
Caesarea,  IL 3088900
Applicant Contact KOBY SHEFFY
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact JONATHAN KAHAN
Regulation Number868.2375
Classification Product Code
MNR  
Date Received10/22/2015
Decision Date 07/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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