FDA 510(k)

EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC

K-Number: K050220 · 2005-02-10

ApplicantOlympus Medical Systems Corporation

Decision Date2005-02-10

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2005-02-10 under 510(k) number K050220. 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 EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC?

EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC is a medical device that received FDA 510(k) clearance on 2005-02-10. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K050220.

When did EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC receive FDA 510(k) clearance?

EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC received FDA 510(k) clearance on 2005-02-10, under 510(k) number K050220.

Who is the listed applicant for EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC?

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

What is the FDA product code for EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC?

The FDA product code for EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC is EOQ.

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Other records listing Olympus Medical Systems Corporation as applicant

K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500 K260856Disposable Distal Attachment D-201-13404 K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LB K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Related Devices (Code: EOQ)

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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.