R-150-ET COLLIMATOR

Collimator, Manual, Radiographic

ADVANTECH

The following data is part of a premarket notification filed by Advantech with the FDA for R-150-et Collimator.

Pre-market Notification Details

Device IDK896486
510k NumberK896486
Device Name:R-150-ET COLLIMATOR
ClassificationCollimator, Manual, Radiographic
Applicant ADVANTECH 16 LAWRENCE ST. Wakefield,  MA  01880
ContactCharles E Moreland
CorrespondentCharles E Moreland
ADVANTECH 16 LAWRENCE ST. Wakefield,  MA  01880
Product CodeIZX  
CFR Regulation Number892.1610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-13
Decision Date1990-01-23

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