DTV-4114 FLUOROSCOPIC TELEVISION CAMERA

Camera, X-ray, Fluorographic, Cine Or Spot

ADAC LABORATORIES

The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Dtv-4114 Fluoroscopic Television Camera.

Pre-market Notification Details

Device IDK881688
510k NumberK881688
Device Name:DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
ClassificationCamera, X-ray, Fluorographic, Cine Or Spot
Applicant ADAC LABORATORIES 540 ALDER DR. Milpitas,  CA  95035
ContactGary L Pembroke
CorrespondentGary L Pembroke
ADAC LABORATORIES 540 ALDER DR. Milpitas,  CA  95035
Product CodeIZJ  
CFR Regulation Number892.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-19
Decision Date1988-05-18

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