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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 K897121
Device Name QEKG ELECTROCARDIOGRAPH
Applicant
Qmed, Inc.
Suite 403
67 Walnut Ave.
Clark,  NJ  07066
Applicant Contact DENISE A QUEFFELEC
Correspondent
Qmed, Inc.
Suite 403
67 Walnut Ave.
Clark,  NJ  07066
Correspondent Contact DENISE A QUEFFELEC
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/26/1989
Decision Date 04/30/1990
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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