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FDA 510(k)

Fujifilm Endoscope Models EC-600HL and EC-600LS

K-Number: K162622 · 2016-10-18

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2016-10-18
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Fujifilm Endoscope Models EC-600HL and EC-600LS is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2016-10-18 under approval number K162622. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fujifilm Endoscope Models EC-600HL and EC-600LS?

Fujifilm Endoscope Models EC-600HL and EC-600LS is a medical device that received FDA 510(k) clearance on 2016-10-18. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K162622.

When was Fujifilm Endoscope Models EC-600HL and EC-600LS approved by the FDA?

Fujifilm Endoscope Models EC-600HL and EC-600LS received FDA 510(k) clearance on 2016-10-18, under approval number K162622.

What company makes Fujifilm Endoscope Models EC-600HL and EC-600LS?

Fujifilm Endoscope Models EC-600HL and EC-600LS is manufactured by Fujifilm Medical Systems U.S.A, Inc..

What is the FDA product code for Fujifilm Endoscope Models EC-600HL and EC-600LS?

The FDA product code for Fujifilm Endoscope Models EC-600HL and EC-600LS is FDF.

Other Devices by Fujifilm Medical Systems U.S.A, Inc.

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Related Devices (Code: FDF)

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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.

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