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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K914206
Device Name ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST
Applicant
Kardiosis Ltd. Co.
C/O New York Informatics Co.
85 4th Ave., Suite 600
New York,  NY  10003
Applicant Contact ABDULLAH TARSEL
Correspondent
Kardiosis Ltd. Co.
C/O New York Informatics Co.
85 4th Ave., Suite 600
New York,  NY  10003
Correspondent Contact ABDULLAH TARSEL
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/19/1991
Decision Date 03/30/1992
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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