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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K926172
Device Name SERIES 1500 DEFIBRILLATOR, MODIFICATION
Applicant
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact GERRY BUSS
Correspondent
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact GERRY BUSS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received12/01/1992
Decision Date 02/25/1993
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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