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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 K203839
Device Name WatchPAT200U (WP200U)
Applicant
Itamar Medical, Ltd.
9 Halamish Street
Casearea,  IL 3088900
Applicant Contact Efrat Litman
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 Received12/30/2020
Decision Date 03/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT01570738
NCT02369705
Reviewed by Third Party No
Combination Product No
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