SHIMADZU X-RAY TUBE STAND FH-31

Tube Mount, X-ray, Diagnostic

SHIMADZU MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Shimadzu X-ray Tube Stand Fh-31.

Pre-market Notification Details

Device IDK895188
510k NumberK895188
Device Name:SHIMADZU X-RAY TUBE STAND FH-31
ClassificationTube Mount, X-ray, Diagnostic
Applicant SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia,  CA  90248
ContactDe Mint
CorrespondentDe Mint
SHIMADZU MEDICAL SYSTEMS 101 WEST WALNUT ST. Gardenia,  CA  90248
Product CodeIYB  
CFR Regulation Number892.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-11
Decision Date1989-09-22

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