ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA

Endoscopic Video Imaging System/component, Gastroenterology-urology

ENDOMEDIX

The following data is part of a premarket notification filed by Endomedix with the FDA for Endoscopic Video System And Endoscopic Video Camera.

Pre-market Notification Details

Device IDK934623
510k NumberK934623
Device Name:ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant ENDOMEDIX 2162 MICHELSON DR. Irvine,  CA  92715 -1304
ContactRandy A Wilson
CorrespondentRandy A Wilson
ENDOMEDIX 2162 MICHELSON DR. Irvine,  CA  92715 -1304
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-27
Decision Date1993-12-02

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