ER-1000 CATHERIZATION C-ARM SYSTEMS

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 Er-1000 Catherization C-arm Systems.

Pre-market Notification Details

Device IDK914348
510k NumberK914348
Device Name:ER-1000 CATHERIZATION C-ARM SYSTEMS
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 Received1991-09-27
Decision Date1991-11-01

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