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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., NE
Redmond,  WA  98073 -9706
Applicant Contact Sylvia Lemke
Correspondent
Physio-Control, Inc.
11811 Willows Rd., NE
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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