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FDA 510(k)

FUJIFILM Bronchoscope Model EB-530P

K-Number: K171291 · 2018-01-19

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2018-01-19
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Bronchoscope Model EB-530P is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K171291. 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 Bronchoscope Model EB-530P?

FUJIFILM Bronchoscope Model EB-530P is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K171291.

When did FUJIFILM Bronchoscope Model EB-530P receive FDA 510(k) clearance?

FUJIFILM Bronchoscope Model EB-530P received FDA 510(k) clearance on 2018-01-19, under 510(k) number K171291.

Who is the listed applicant for FUJIFILM Bronchoscope Model EB-530P?

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

What is the FDA product code for FUJIFILM Bronchoscope Model EB-530P?

The FDA product code for FUJIFILM Bronchoscope Model EB-530P is EOQ.

Other records listing Fujifilm Medical Systems U.S.A, Inc. as applicant

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Related Devices (Code: EOQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology 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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