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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K052707
Device Name M3046B COMPACT PORTABLE PATIENT MONITORS
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Applicant Contact MICHAEL J DOYLE
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Correspondent Contact MICHAEL J DOYLE
Regulation Number870.1025
Classification Product Code
MHX  
Date Received09/29/2005
Decision Date 10/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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