DR-2C

Display, Cathode-ray Tube, Medical

GENERAL DEVICES

The following data is part of a premarket notification filed by General Devices with the FDA for Dr-2c.

Pre-market Notification Details

Device IDK844650
510k NumberK844650
Device Name:DR-2C
ClassificationDisplay, Cathode-ray Tube, Medical
Applicant GENERAL DEVICES 86 HARRIET AVE. Bergenfield,  NJ  07621
ContactMichael Smith
CorrespondentMichael Smith
GENERAL DEVICES 86 HARRIET AVE. Bergenfield,  NJ  07621
Product CodeDXJ  
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-29
Decision Date1985-01-22

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