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FDA 510(k) Application Details - K102974
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
510(K) Number
K102974
Device Name
System,Network And Communication,Physiological Monitors
Applicant
PHILIPS MEDICAL SYSTEMS
6400 N. CONGRESS AVE.
SUITE 1050
BOCA RATON, FL 33487-2810 US
Other 510(k) Applications for this Company
Contact
GARY BECKER
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/06/2010
Decision Date
01/04/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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