IntelliVue Patient Monitor

Detector And Alarm, Arrhythmia

PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH

The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Intellivue Patient Monitor.

Pre-market Notification Details

Device IDK151681
510k NumberK151681
Device Name:IntelliVue Patient Monitor
ClassificationDetector And Alarm, Arrhythmia
Applicant PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen,  DE 71034
ContactJohannes Schmid
CorrespondentJohannes Schmid
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen,  DE 71034
Product CodeDSI  
Subsequent Product CodeDRQ
Subsequent Product CodeDSJ
Subsequent Product CodeDSK
Subsequent Product CodeDXG
Subsequent Product CodeDXN
Subsequent Product CodeMHX
Subsequent Product CodeMLD
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-22
Decision Date2015-07-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838073579 K151681 000
00884838072251 K151681 000
00884838051492 K151681 000
10884838073583 K151681 000

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