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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 K983393
Device Name LIFEPAK 500 BIPHASIC
Applicant
Physio-Control Corp.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073
Applicant Contact SHERRI L POCOCK
Correspondent
Physio-Control Corp.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073
Correspondent Contact SHERRI L POCOCK
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/25/1998
Decision Date 05/05/1999
Decision SE SUBJECT TO TRACKING REG (ST)
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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