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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
510(k) Number K253099
Device Name LIFEPAK 15 AC Power Adapter (41577-000333)
Applicant
Physio-Control, Inc.
11811 Willows Rd. NE
Redmond,  WA  98052
Applicant Contact Elisha McGaff
Correspondent
Physio-Control, Inc.
11811 Willows Rd. NE
Redmond,  WA  98052
Correspondent Contact Elisha McGaff
Regulation Number870.5300
Classification Product Code
MPD  
Date Received09/24/2025
Decision Date 10/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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