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FDA 510(k) Application Details - K000638
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K000638
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
MUNZINGER STR. 3
FREIBURG 79111 DE
Other 510(k) Applications for this Company
Contact
KLAUS RUDOLF
Other 510(k) Applications for this Contact
Regulation Number
870.5310
More FDA Info for this Regulation Number
Classification Product Code
MKJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/25/2000
Decision Date
10/30/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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