LEICA FL800

System, X-ray, Angiographic

LEICA MICROSYSTEMS (SCHWEIZ) AG

The following data is part of a premarket notification filed by Leica Microsystems (schweiz) Ag with the FDA for Leica Fl800.

Pre-market Notification Details

Device IDK080612
510k NumberK080612
Device Name:LEICA FL800
ClassificationSystem, X-ray, Angiographic
Applicant LEICA MICROSYSTEMS (SCHWEIZ) AG 1717 WEST COLLINS Orange,  CA  92867
ContactColleen Boswell
CorrespondentColleen Boswell
LEICA MICROSYSTEMS (SCHWEIZ) AG 1717 WEST COLLINS Orange,  CA  92867
Product CodeIZI  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-04
Decision Date2008-05-09
Summary:summary

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