PHYSIOLOGICAL MONITOR, PATIENT MONITOR

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN

The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Physiological Monitor, Patient Monitor.

Pre-market Notification Details

Device IDK113441
510k NumberK113441
Device Name:PHYSIOLOGICAL MONITOR, PATIENT MONITOR
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 71034
ContactJens-peter Seher
CorrespondentJens-peter Seher
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen,  DE D 71034
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-21
Decision Date2012-03-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838021563 K113441 000
20884838071340 K113441 000
20884838071388 K113441 000
20884838071401 K113441 000
20884838071425 K113441 000
20884838071432 K113441 000
20884838071449 K113441 000
20884838071456 K113441 000
20884838071463 K113441 000
20884838071319 K113441 000

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