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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K932109
Device Name PROFILOMAT
Applicant
Qmed, Inc.
100 Metro Park S.
3rd Floor
Laurence Harbor,  NJ  08878
Applicant Contact DENISE QUEFFELEC
Correspondent
Qmed, Inc.
100 Metro Park S.
3rd Floor
Laurence Harbor,  NJ  08878
Correspondent Contact DENISE QUEFFELEC
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/03/1993
Decision Date 12/03/1993
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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