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FDA 510(k) Application Details - K161164
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
510(K) Number
K161164
Device Name
System,Network And Communication,Physiological Monitors
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN ROAD
ANDOVER, MA 01810 US
Other 510(k) Applications for this Company
Contact
Theresa Poole
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
04/25/2016
Decision Date
06/24/2016
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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