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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 K020715
FOIA Releasable 510(k) K020715
Device Name PHILIPS M5066A AND M5068A
Applicant
PHILIPS MEDICAL SYSTEMS
2301 FIFTH AVE., SUITE 200
SEATTLE,  WA  98121
Applicant Contact TAMARA YOUNT
Correspondent
PHILIPS MEDICAL SYSTEMS
2301 FIFTH AVE., SUITE 200
SEATTLE,  WA  98121
Correspondent Contact TAMARA YOUNT
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received03/05/2002
Decision Date 11/08/2002
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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