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FDA 510(k) Application Details - K182979
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K182979
Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard Str. 2
Boeblingen 71034 DE
Other 510(k) Applications for this Company
Contact
Markus Stacha
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
10/26/2018
Decision Date
11/19/2019
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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