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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 K102567
Device Name WATCH-PAT 200S-3 (WP200S-3)
Applicant
ITAMAR MEDICAL LTD
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN KAHN
Correspondent
ITAMAR MEDICAL LTD
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN KAHN
Regulation Number868.2375
Classification Product Code
MNR  
Date Received09/07/2010
Decision Date 06/02/2011
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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