UNIX-LINK

Camera, Scintillation (gamma)

GENERAL ELECTRIC CO.

The following data is part of a premarket notification filed by General Electric Co. with the FDA for Unix-link.

Pre-market Notification Details

Device IDK926550
510k NumberK926550
Device Name:UNIX-LINK
ClassificationCamera, Scintillation (gamma)
Applicant GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee,  WI  53201
ContactLarry A Kroger
CorrespondentLarry A Kroger
GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee,  WI  53201
Product CodeIYX  
CFR Regulation Number892.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-31
Decision Date1993-03-18

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