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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K841172
Device Name MONITOR ONE
Applicant
Qmed, Inc.
Suite 403
67 Walnut Ave.
Clark,  NJ  07066
Applicant Contact RICHARD I LEVINE
Correspondent
Qmed, Inc.
Suite 403
67 Walnut Ave.
Clark,  NJ  07066
Correspondent Contact RICHARD I LEVINE
Regulation Number870.1025
Classification Product Code
DSI  
Date Received03/19/1984
Decision Date 07/27/1984
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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