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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 K122600
Device Name LIFEPAK 1000 DEFIBRILLATOR
Original Applicant
PHYSIO-CONTROL, INC.
11811 willows rd., n.e.
po box 97006
redmond,  WA  98073 9706
Original Contact michelle ackermann
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received08/27/2012
Decision Date 10/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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