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FDA 510(k) Application Details - K063510
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K063510
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
11811 WILLOWS RD., N.E.
P.O. BOX 97006
REDMOND, WA 98073-9706 US
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Contact
MICHELLE ACKERMANN
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
11/20/2006
Decision Date
01/26/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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