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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 K250460
Device Name WatchPAT400 (WP400)
Applicant
Itamar Medical , Ltd.
9 Halamish St.
Caesarea,  IL 3088900
Applicant Contact Dafna Raiman
Correspondent
Hogan Lovells US LLP
555 13 St. NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number868.2375
Classification Product Code
MNR  
Date Received02/18/2025
Decision Date 09/05/2025
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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