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FDA 510(k)

MORPHEUS OX

K-Number: K111314 · 2011-08-31

ApplicantWidemed, Ltd.
Decision Date2011-08-31
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MORPHEUS OX is the device name listed in this FDA 510(k) record. The listed applicant is Widemed, Ltd.. It received FDA 510(k) clearance on 2011-08-31 under 510(k) number K111314. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MORPHEUS OX?

MORPHEUS OX is a medical device that received FDA 510(k) clearance on 2011-08-31. The listed applicant is Widemed, Ltd.. The 510(k) number is K111314.

When did MORPHEUS OX receive FDA 510(k) clearance?

MORPHEUS OX received FDA 510(k) clearance on 2011-08-31, under 510(k) number K111314.

Who is the listed applicant for MORPHEUS OX?

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

What is the FDA product code for MORPHEUS OX?

The FDA product code for MORPHEUS OX is MNR.

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Other records listing Widemed, Ltd. 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.

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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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