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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 K010918
Device Name LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
Applicant
Medtronic Physio-Control Corp.
11811 Willows Rd., NE
Redmond,  WA  98073
Applicant Contact SHERRI L POCOCK
Correspondent
Medtronic Physio-Control Corp.
11811 Willows Rd., NE
Redmond,  WA  98073
Correspondent Contact SHERRI L POCOCK
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
LDD   MWI  
Date Received03/27/2001
Decision Date 08/23/2001
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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