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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K921765
Device Name PRIMEDIC DEFIBRILLATORS-N/B
Applicant
Metronic Electronic GmbH
5215 Terrell Ln.
Hampton,  VA  23666
Applicant Contact DIANE R CALDAROLA
Correspondent
Metronic Electronic GmbH
5215 Terrell Ln.
Hampton,  VA  23666
Correspondent Contact DIANE R CALDAROLA
Regulation Number870.5300
Classification Product Code
LDD  
Date Received04/14/1992
Decision Date 03/03/1993
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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