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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 K011144
Device Name LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
Applicant
MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD NE BX 97006
REDMOND,  WA  98073 -9706
Applicant Contact SHERRI L POCOCK
Correspondent
MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD NE BX 97006
REDMOND,  WA  98073 -9706
Correspondent Contact SHERRI L POCOCK
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received04/16/2001
Decision Date 12/03/2001
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
Recalls CDRH Recalls
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