ALLURA XPER FD10

System, X-ray, Angiographic

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.

The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Allura Xper Fd10.

Pre-market Notification Details

Device IDK041949
510k NumberK041949
Device Name:ALLURA XPER FD10
ClassificationSystem, X-ray, Angiographic
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. VEENPLUIS 4-6- 5684 PC BEST The Netherlands,  NL
ContactLynn Harmer
CorrespondentLynn Harmer
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. VEENPLUIS 4-6- 5684 PC BEST The Netherlands,  NL
Product CodeIZI  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-20
Decision Date2004-07-30
Summary:summary

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