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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 K895651
Device Name MARQUETTE 1200 DEFIBRILLATION PADS
Applicant
Marquette Electronics, Inc.
8 Ballo Dr., Balloo Indus.
Estate, Bangor, Co. Down,
N. Ireland Bt19 2qy,  GB
Applicant Contact OMAR BEGGS
Correspondent
Marquette Electronics, Inc.
8 Ballo Dr., Balloo Indus.
Estate, Bangor, Co. Down,
N. Ireland Bt19 2qy,  GB
Correspondent Contact OMAR BEGGS
Regulation Number870.5300
Classification Product Code
LDD  
Date Received09/20/1989
Decision Date 12/12/1989
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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