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FDA 510(k)

FUJIFILM Endoscope Model EG-530N

K-Number: K183686 · 2019-02-28

ApplicantFujifilm Corporation
Decision Date2019-02-28
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Endoscope Model EG-530N is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-02-28 under approval number K183686. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Endoscope Model EG-530N?

FUJIFILM Endoscope Model EG-530N is a medical device that received FDA 510(k) clearance on 2019-02-28. It is manufactured by Fujifilm Corporation. The 510(k) number is K183686.

When was FUJIFILM Endoscope Model EG-530N approved by the FDA?

FUJIFILM Endoscope Model EG-530N received FDA 510(k) clearance on 2019-02-28, under approval number K183686.

What company makes FUJIFILM Endoscope Model EG-530N?

FUJIFILM Endoscope Model EG-530N is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Endoscope Model EG-530N?

The FDA product code for FUJIFILM Endoscope Model EG-530N is FDS.

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Related Devices (Code: FDS)

K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. K180292PENTAX Video Upper G.I. Scope EG34-i10Pentax Medical of America, Inc. K180341FUJIFILM 600 Series Endoscope EG-600WR v2Fujifilm Corporation K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation K180911Visura Technologies TEECAD SystemVisura Technologies, LLC

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.

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