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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 K183559
Device Name WatchPAT ONE
Applicant
Itamar Medical , Ltd.
9 Halamish St.
Caesarea,  IL
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 Received12/20/2018
Decision Date 06/05/2019
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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