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FDA 510(k)

FUJIFILM Ultrasonic Endoscope

K-Number: K182825 · 2019-02-22

Decision Date2019-02-22
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Ultrasonic Endoscope is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-02-22 under approval number K182825. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Ultrasonic Endoscope?

FUJIFILM Ultrasonic Endoscope is a medical device that received FDA 510(k) clearance on 2019-02-22. It is manufactured by Fujifilm Corporation. The 510(k) number is K182825.

When was FUJIFILM Ultrasonic Endoscope approved by the FDA?

FUJIFILM Ultrasonic Endoscope received FDA 510(k) clearance on 2019-02-22, under approval number K182825.

What company makes FUJIFILM Ultrasonic Endoscope?

FUJIFILM Ultrasonic Endoscope is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Ultrasonic Endoscope?

The FDA product code for FUJIFILM Ultrasonic Endoscope is EOQ.

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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.