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FDA 510(k) Application Details - K180017
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K180017
Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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
870.1025
More FDA Info for this Regulation Number
Classification Product Code
MHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/02/2018
Decision Date
07/24/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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