ULTRANET-S COLLIMATOR

Collimator, Automatic, Radiographic

GE MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ultranet-s Collimator.

Pre-market Notification Details

Device IDK894142
510k NumberK894142
Device Name:ULTRANET-S COLLIMATOR
ClassificationCollimator, Automatic, Radiographic
Applicant GE MEDICAL SYSTEMS PO BOX 414 Milwaukee,  WI  53201
ContactLarry Kroger
CorrespondentLarry Kroger
GE MEDICAL SYSTEMS PO BOX 414 Milwaukee,  WI  53201
Product CodeIZW  
CFR Regulation Number892.1610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-13
Decision Date1989-11-06

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