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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K000609
FOIA Releasable 510(k) K000609
Device Name CARDTEL, MODEL NT-100
Applicant
CARDIAC TELECOMMUNICATIONS
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071 -3404
Applicant Contact J. HARVEY KNAUSS
Correspondent
CARDIAC TELECOMMUNICATIONS
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071 -3404
Correspondent Contact J. HARVEY KNAUSS
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received02/23/2000
Decision Date 05/23/2000
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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