FDA 510(k)

ENDOSCOPIC ULTRASOUND CENTER EU-Y0008

K-Number: K130058 · 2013-02-22

Decision Date2013-02-22

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2013-02-22 under 510(k) number K130058. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC ULTRASOUND CENTER EU-Y0008?

ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 is a medical device that received FDA 510(k) clearance on 2013-02-22. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K130058.

When did ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 receive FDA 510(k) clearance?

ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 received FDA 510(k) clearance on 2013-02-22, under 510(k) number K130058.

Who is the listed applicant for ENDOSCOPIC ULTRASOUND CENTER EU-Y0008?

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

What is the FDA product code for ENDOSCOPIC ULTRASOUND CENTER EU-Y0008?

The FDA product code for ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 is IYN.

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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.