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FDA 510(k)

OSFERION

K-Number: K061499 · 2007-01-26

ApplicantOlympus America, Inc.
Decision Date2007-01-26
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSFERION is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 2007-01-26 under 510(k) number K061499. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSFERION?

OSFERION is a medical device that received FDA 510(k) clearance on 2007-01-26. The listed applicant is Olympus America, Inc.. The 510(k) number is K061499.

When did OSFERION receive FDA 510(k) clearance?

OSFERION received FDA 510(k) clearance on 2007-01-26, under 510(k) number K061499.

Who is the listed applicant for OSFERION?

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

What is the FDA product code for OSFERION?

The FDA product code for OSFERION is MQV.

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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.

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