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FDA 510(k)

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR

K-Number: K162749 · 2017-06-15

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2017-06-15
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-06-15 under approval number K162749. 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 Hood Models DH-28GR, DH-29CR and DH-30CR?

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR is a medical device that received FDA 510(k) clearance on 2017-06-15. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K162749.

When was FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR approved by the FDA?

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR received FDA 510(k) clearance on 2017-06-15, under approval number K162749.

What company makes FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR?

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR is manufactured by Fujifilm Medical Systems U.S.A, Inc..

What is the FDA product code for FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR?

The FDA product code for FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR 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. 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 K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut typeSumitomo Bakelite Co., Ltd.

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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