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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 K000638
Device Name RESPONDER 3000
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
MUNZINGER STR. 3
FREIBURG,  DE 79111
Applicant Contact KLAUS RUDOLF
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
MUNZINGER STR. 3
FREIBURG,  DE 79111
Correspondent Contact KLAUS RUDOLF
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DQA   LDD  
Date Received02/25/2000
Decision Date 10/30/2000
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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