PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER

System, X-ray, Fluoroscopic, Image-intensified

PERKINS MFG. CO.

The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for Pk2025/pk2045 Programmable Video Controller.

Pre-market Notification Details

Device IDK893644
510k NumberK893644
Device Name:PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas,  TX  75204
ContactJames C Furse
CorrespondentJames C Furse
PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas,  TX  75204
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-15
Decision Date1989-08-09

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