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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 K142430
Device Name LIFEPAK 15 monitor/defibrillator
Applicant
PHYSIO-CONTROL, INC.
11811 WILLOWS RD., N.E.
redmond,  WA  98073 -9706
Applicant Contact sylvia lemke
Correspondent
PHYSIO-CONTROL, INC.
11811 WILLOWS RD., N.E.
redmond,  WA  98073 -9706
Correspondent Contact sylvia lemke
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DQA   DRO   DRT   DSK  
DXN   FLL   LDD  
Date Received08/29/2014
Decision Date 12/19/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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