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FDA 510(k)

BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM

K-Number: K040940 · 2004-04-19

ApplicantOlympus Corporation
Decision Date2004-04-19
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corporation. It received FDA 510(k) clearance on 2004-04-19 under 510(k) number K040940. 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 BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM?

BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM is a medical device that received FDA 510(k) clearance on 2004-04-19. The listed applicant is Olympus Corporation. The 510(k) number is K040940.

When did BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM receive FDA 510(k) clearance?

BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM received FDA 510(k) clearance on 2004-04-19, under 510(k) number K040940.

Who is the listed applicant for BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM?

The FDA 510(k) record lists Olympus Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM?

The FDA product code for BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM is EOQ.

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Other records listing Olympus Corporation as applicant

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.

K072643CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/USK043128OLYMPUS ENDOARMK042140OLYMPUS BF TYPE UC160-OL8K041494OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2

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.

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/SK2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

Official Source

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

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