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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 (Acor Dc) For External Transcutaneous Cardiac Pacemaker
510(k) Number K945511
Device Name LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR
Applicant
Physio-Control Corp.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073 -9706
Applicant Contact MICHAEL D WILLINGHAM
Correspondent
Physio-Control Corp.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073 -9706
Correspondent Contact MICHAEL D WILLINGHAM
Regulation Number870.5550
Classification Product Code
MPE  
Date Received11/09/1994
Decision Date 09/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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