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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 K222331
Device Name WatchPAT300 (WP300)
Applicant
Itamar Medical , Ltd.
9 Halamish St.
Caesarea,  IL 3088900
Applicant Contact Efrat Litman
Correspondent
Hogan Lovells US LLP
553 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact Jonathan Kahan
Regulation Number868.2375
Classification Product Code
MNR  
Date Received08/02/2022
Decision Date 09/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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