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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K001852
FOIA Releasable 510(k) K001852
Device Name PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
Applicant
Itamar Medical (C.M.) 1997 , Ltd.
P.O.B. 454
Ginot Shomron 44853,  IL 44853
Applicant Contact AHAVA STEIN
Correspondent
Itamar Medical (C.M.) 1997 , Ltd.
P.O.B. 454
Ginot Shomron 44853,  IL 44853
Correspondent Contact AHAVA STEIN
Regulation Number870.1425
Classification Product Code
DQK  
Date Received06/19/2000
Decision Date 02/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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