Philips Hemodynamic Application R1.0

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

Philips Medical Systems Nederlands B.V.

The following data is part of a premarket notification filed by Philips Medical Systems Nederlands B.v. with the FDA for Philips Hemodynamic Application R1.0.

Pre-market Notification Details

Device IDK181311
510k NumberK181311
Device Name:Philips Hemodynamic Application R1.0
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant Philips Medical Systems Nederlands B.V. Veenpluis 4-6 Best,  NL 5684pc
ContactOwen Callaghan
CorrespondentOwen Callaghan
Philips Medical Systems Nederlands B.V. Veenpluis 4-6 Best,  NL 5684pc
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-17
Decision Date2018-09-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838084544 K181311 000

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