XPERGUIDE

Interventional Fluoroscopic X-ray System

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Xperguide.

Pre-market Notification Details

Device IDK131263
510k NumberK131263
Device Name:XPERGUIDE
ClassificationInterventional Fluoroscopic X-ray System
Applicant PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best,  NL 5684 Pc
ContactJos V Vroonhoven
CorrespondentJos V Vroonhoven
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best,  NL 5684 Pc
Product CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-03
Decision Date2013-07-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838059252 K131263 000

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