BI-N

System, X-ray, Angiographic

XRE CORP.

The following data is part of a premarket notification filed by Xre Corp. with the FDA for Bi-n.

Pre-market Notification Details

Device IDK924828
510k NumberK924828
Device Name:BI-N
ClassificationSystem, X-ray, Angiographic
Applicant XRE CORP. 300 FOSTER ST. Littleton,  MA  01460
ContactRichard A Zablocki
CorrespondentRichard A Zablocki
XRE CORP. 300 FOSTER ST. Littleton,  MA  01460
Product CodeIZI  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-28
Decision Date1992-12-17

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