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FDA 510(k)

OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER

K-Number: K043275 · 2004-12-09

ApplicantOlympus Medical Systems Corporation
Decision Date2004-12-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER 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 2004-12-09 under 510(k) number K043275. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER?

OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER is a medical device that received FDA 510(k) clearance on 2004-12-09. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K043275.

When did OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER receive FDA 510(k) clearance?

OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER received FDA 510(k) clearance on 2004-12-09, under 510(k) number K043275.

Who is the listed applicant for OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER?

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 OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER?

The FDA product code for OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER is IYO.

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Other records listing Olympus Medical Systems 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.

K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500K260856Disposable Distal Attachment D-201-13404K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LBK252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Related Devices (Code: IYO)

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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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