Patient Information Center IX

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

Philips Medizin Systeme Böblingen GmbH

The following data is part of a premarket notification filed by Philips Medizin Systeme Böblingen Gmbh with the FDA for Patient Information Center Ix.

Pre-market Notification Details

Device IDK211900
510k NumberK211900
Device Name:Patient Information Center IX
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Str.2 Böblingen,  DE 71034
ContactPeng Cui
CorrespondentPeng Cui
Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Str.2 Böblingen,  DE 71034
Product CodeMHX  
Subsequent Product CodeDSH
Subsequent Product CodeDSI
Subsequent Product CodeMLD
Subsequent Product CodeMSX
Subsequent Product CodeOUG
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-21
Decision Date2022-03-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838104594 K211900 000
00884838112070 K211900 000
00884838121782 K211900 000
00884838122772 K211900 000

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