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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K842624
Device Name LIFEPAK 8
Applicant
Physio-Control Corp.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073
Applicant Contact MICHAEL B GROPP
Correspondent
Physio-Control Corp.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073
Correspondent Contact MICHAEL B GROPP
Regulation Number870.5300
Classification Product Code
LDD  
Date Received07/05/1984
Decision Date 10/18/1984
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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