FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE

Transducer, Ultrasonic, Diagnostic

PENTAX PRECISION INSTRUMENT CORP.

The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fg-36ux, Ultrasound Upper Gi Fiberscope.

Pre-market Notification Details

Device IDK961974
510k NumberK961974
Device Name:FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar,  FL  33025
ContactPaul Silva
CorrespondentPaul Silva
PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar,  FL  33025
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-20
Decision Date1997-02-10
Summary:summary

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