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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 K042404
Device Name LIFEPAK, MODEL 1000
Applicant
Medtronic Emergency Response Systems, Inc.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073
Applicant Contact SHERRI POCOCK
Correspondent
Medtronic Emergency Response Systems, Inc.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073
Correspondent Contact SHERRI POCOCK
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/03/2004
Decision Date 12/22/2005
Decision Substantially Equivalent (SESE)
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
Recalls CDRH Recalls
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