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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 Street, 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
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