X-RAY COLLIMATOR

Collimator, X-ray

GENERAL X-RAY, INC.

The following data is part of a premarket notification filed by General X-ray, Inc. with the FDA for X-ray Collimator.

Pre-market Notification Details

Device IDK781675
510k NumberK781675
Device Name:X-RAY COLLIMATOR
ClassificationCollimator, X-ray
Applicant GENERAL X-RAY, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEHB  
CFR Regulation Number872.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-09-29
Decision Date1978-12-04

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