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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 K082937
Device Name LIFEPAK 15 MONITOR/DEFIBRILLATOR
Applicant
Physio-Control, Inc.
11811 Willows Rd. NE, P.O. Box 97006
Redmond,  WA  98052
Applicant Contact TERESA DAVIDSON
Correspondent
Physio-Control, Inc.
11811 Willows Rd. NE, P.O. Box 97006
Redmond,  WA  98052
Correspondent Contact TERESA DAVIDSON
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DQA   DRO   DRT   DSK  
DXN   LDD  
Date Received10/01/2008
Decision Date 03/11/2009
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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