MD100 & MM150

Screen, Intensifying, Radiographic

KONICA MEDICAL CORP.

The following data is part of a premarket notification filed by Konica Medical Corp. with the FDA for Md100 & Mm150.

Pre-market Notification Details

Device IDK963913
510k NumberK963913
Device Name:MD100 & MM150
ClassificationScreen, Intensifying, Radiographic
Applicant KONICA MEDICAL CORP. THE CHRYSLER BUILDING 405 LEXINGTON AVENUE New York,  NY  10174
ContactRussell D Munves
CorrespondentRussell D Munves
KONICA MEDICAL CORP. THE CHRYSLER BUILDING 405 LEXINGTON AVENUE New York,  NY  10174
Product CodeEAM  
CFR Regulation Number892.1960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-30
Decision Date1997-10-08

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