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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 K153070
Device Name Watch-PAT200U
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 -1109
Correspondent Contact JONATHAN KAHAN
Regulation Number868.2375
Classification Product Code
MNR  
Date Received10/22/2015
Decision Date 07/26/2016
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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