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FDA 510(k)

FUJIFILM Duodenoscope Model

K-Number: K181745 · 2019-03-28

Decision Date2019-03-28
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Duodenoscope Model is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-03-28 under approval number K181745. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Duodenoscope Model?

FUJIFILM Duodenoscope Model is a medical device that received FDA 510(k) clearance on 2019-03-28. It is manufactured by Fujifilm Corporation. The 510(k) number is K181745.

When was FUJIFILM Duodenoscope Model approved by the FDA?

FUJIFILM Duodenoscope Model received FDA 510(k) clearance on 2019-03-28, under approval number K181745.

What company makes FUJIFILM Duodenoscope Model?

FUJIFILM Duodenoscope Model is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Duodenoscope Model?

The FDA product code for FUJIFILM Duodenoscope Model is FDT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.