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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K910450
Device Name CARD GUARD-3000 ECG TELEPHONE ADAPTER
Applicant
Medtech Industries, Inc.
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Medtech Industries, Inc.
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number870.2920
Classification Product Code
DXH  
Date Received02/01/1991
Decision Date 05/07/1991
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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