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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 K061707
Device Name HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
M/S 0220
ANDOVER,  MA  01810
Applicant Contact SONGHUA ZHANG
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
M/S 0220
ANDOVER,  MA  01810
Correspondent Contact SONGHUA ZHANG
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received06/16/2006
Decision Date 08/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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