ALLURA XPER FD20

Interventional Fluoroscopic X-ray System

PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Allura Xper Fd20.

Pre-market Notification Details

Device IDK033737
510k NumberK033737
Device Name:ALLURA XPER FD20
ClassificationInterventional Fluoroscopic X-ray System
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best,  NL 5680
ContactLynn Harmer
CorrespondentLynn Harmer
UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas,  WA  98607 -9526
Product CodeOWB  
Subsequent Product CodeIZI
Subsequent Product CodeJAA
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-11-28
Decision Date2003-12-09
Summary:summary

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