FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L And EC-740T/L

Gastroscope And Accessories, Flexible/rigid

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Endoscope Models Eg-760ct, Ec-760p-v/l And Ec-740t/l.

Pre-market Notification Details

Device IDK183572
510k NumberK183572
Device Name:FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L And EC-740T/L
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentJeffrey Wan
FUJIFILM Medical Systems U.S.A., Inc. 419 West Ave Stamford,  CT  06902
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-21
Decision Date2019-07-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14547410368878 K183572 000
04547410368864 K183572 000
14547410368854 K183572 000

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