ADAC MODEL ARC-5000, GAMMA CAMERA

System, Tomographic, Nuclear

ADAC LABORATORIES

The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Adac Model Arc-5000, Gamma Camera.

Pre-market Notification Details

Device IDK873075
510k NumberK873075
Device Name:ADAC MODEL ARC-5000, GAMMA CAMERA
ClassificationSystem, Tomographic, Nuclear
Applicant ADAC LABORATORIES 540 ALDER DR. Milpitas,  CA  95035
ContactGary L Pembroke
CorrespondentGary L Pembroke
ADAC LABORATORIES 540 ALDER DR. Milpitas,  CA  95035
Product CodeJWM  
CFR Regulation Number892.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-06
Decision Date1987-10-30

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