BUCKY STAND BR-10M

System, X-ray, Stationary

SHIMADZU CORP.

The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Bucky Stand Br-10m.

Pre-market Notification Details

Device IDK942792
510k NumberK942792
Device Name:BUCKY STAND BR-10M
ClassificationSystem, X-ray, Stationary
Applicant SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance,  CA  90502 -1328
ContactMichael Fishback
CorrespondentMichael Fishback
SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance,  CA  90502 -1328
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-14
Decision Date1994-07-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.