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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 K872928
Device Name LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH
Applicant
Fidelity Medical, Inc.
306 Main St.
P.O. Box 594
Millburn,  NJ  07041
Applicant Contact EFRAIM E LANDA
Correspondent
Fidelity Medical, Inc.
306 Main St.
P.O. Box 594
Millburn,  NJ  07041
Correspondent Contact EFRAIM E LANDA
Regulation Number870.1425
Classification Product Code
DQK  
Date Received07/27/1987
Decision Date 01/06/1988
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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