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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 K002445
Device Name LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES
Applicant
Medtronic Physio-Control Corp.
11811 Willows Rd., NE
Redmond,  WA  98073
Applicant Contact BOB ZITO
Correspondent
Medtronic Physio-Control Corp.
11811 Willows Rd., NE
Redmond,  WA  98073
Correspondent Contact BOB ZITO
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
DSK  
Date Received08/09/2000
Decision Date 01/31/2001
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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