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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 K103567
Device Name LIFEPAK 15 MONITOR/DEFIBRILLATOR
Applicant
Physio-Control, Inc.
11811 Willows Rd. NE
Redmond,  WA  98052
Applicant Contact MICHELLE ACKERMANN
Correspondent
Physio-Control, Inc.
11811 Willows Rd. NE
Redmond,  WA  98052
Correspondent Contact MICHELLE ACKERMANN
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received12/06/2010
Decision Date 03/22/2011
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
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