FDA 510(k)

FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US

K-Number: K121035 · 2012-06-04

ApplicantFujifilm Medical System U.S.A., Inc.

Decision Date2012-06-04

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2012-06-04 under 510(k) number K121035. 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 FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US?

FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US is a medical device that received FDA 510(k) clearance on 2012-06-04. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K121035.

When did FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US receive FDA 510(k) clearance?

FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US received FDA 510(k) clearance on 2012-06-04, under 510(k) number K121035.

Who is the listed applicant for FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US?

The FDA 510(k) record lists Fujifilm Medical System U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US?

The FDA product code for FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US is EOQ.

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Related Devices (Code: EOQ)

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Official Source

View on FDA Database →

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