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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 K180775
Device Name Watch-PAT300
Applicant
Itamar Medical, Ltd.
9 Halamish St.
Caesarea,  IL 3088900
Applicant Contact Koby Sheffy
Correspondent
Hogan Lovells US, LLP
555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact Jonathan Kahan
Regulation Number868.2375
Classification Product Code
MNR  
Date Received03/23/2018
Decision Date 08/17/2018
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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