ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES

Interventional Fluoroscopic X-ray System

PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.

The following data is part of a premarket notification filed by Philips Medical Systems Netherland, B.v. with the FDA for Allura Xper Fd Series / Allura Xper Or Table Series.

Pre-market Notification Details

Device IDK141979
510k NumberK141979
Device Name:ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
ClassificationInterventional Fluoroscopic X-ray System
Applicant PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V. VEENPLUIS 4-6 5684-PC Best,  NL Netherland
ContactJeanette Becker
CorrespondentJeanette Becker
PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V. VEENPLUIS 4-6 5684-PC Best,  NL Netherland
Product CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-21
Decision Date2014-08-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838059122 K141979 000
00884838054196 K141979 000
00884838054202 K141979 000
00884838054219 K141979 000
00884838054226 K141979 000
00884838054233 K141979 000
00884838054240 K141979 000
00884838054257 K141979 000
00884838054264 K141979 000
00884838054271 K141979 000
00884838059115 K141979 000
00884838054189 K141979 000

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