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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
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