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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 K903774
Device Name LP-PLUS
Applicant
Fidelity Medical, Inc.
6 Vreeland Rd.
Florham Park,  NJ  07932
Applicant Contact AMIR RIPPEL
Correspondent
Fidelity Medical, Inc.
6 Vreeland Rd.
Florham Park,  NJ  07932
Correspondent Contact AMIR RIPPEL
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/20/1990
Decision Date 08/29/1991
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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