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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 K924544
Device Name CARDIAX
Applicant
Fairlake Marketing Group, Inc.
1223 Fairlake Trace,
Suite 802
Ft. Lauderdale,  FL  33326
Applicant Contact STEVEN W GARGANO
Correspondent
Fairlake Marketing Group, Inc.
1223 Fairlake Trace,
Suite 802
Ft. Lauderdale,  FL  33326
Correspondent Contact STEVEN W GARGANO
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/08/1992
Decision Date 07/29/1993
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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