Philips IntelliSpace Cardiovascular

System, Image Processing, Radiological

PHILIPS MEDICAL SYSTEMS NETHRLANDS BV

The following data is part of a premarket notification filed by Philips Medical Systems Nethrlands Bv with the FDA for Philips Intellispace Cardiovascular.

Pre-market Notification Details

Device IDK153022
510k NumberK153022
Device Name:Philips IntelliSpace Cardiovascular
ClassificationSystem, Image Processing, Radiological
Applicant PHILIPS MEDICAL SYSTEMS NETHRLANDS BV VEENPLUIS 4-6 Best,  NL 5684 Pc
ContactDave J.w. Bierhuizen
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2015-10-15
Decision Date2015-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838091429 K153022 000
00884838100107 K153022 000
00884838115378 K153022 000
00884838106970 K153022 000
00884838095250 K153022 000
00884838093072 K153022 000
00884838075214 K153022 000
00884838085220 K153022 000
00884838085770 K153022 000
00884838087460 K153022 000
00884838122000 K153022 000

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