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FDA 510(k)

Morpheus-C

K-Number: K190371 · 2019-08-09

ApplicantBiogennix, LLC
Decision Date2019-08-09
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Morpheus-C is the device name listed in this FDA 510(k) record. The listed applicant is Biogennix, LLC. It received FDA 510(k) clearance on 2019-08-09 under 510(k) number K190371. 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 Morpheus-C?

Morpheus-C is a medical device that received FDA 510(k) clearance on 2019-08-09. The listed applicant is Biogennix, LLC. The 510(k) number is K190371.

When did Morpheus-C receive FDA 510(k) clearance?

Morpheus-C received FDA 510(k) clearance on 2019-08-09, under 510(k) number K190371.

Who is the listed applicant for Morpheus-C?

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

What is the FDA product code for Morpheus-C?

The FDA product code for Morpheus-C is MQV.

Other records listing Biogennix, LLC as applicant

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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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