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FDA 510(k)

Perseus

K-Number: K192653 · 2020-09-09

ApplicantOrthokey Italia S.R.L.
Decision Date2020-09-09
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Perseus is a medical device manufactured by Orthokey Italia S.R.L.. It received FDA 510(k) clearance on 2020-09-09 under approval number K192653. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Perseus?

Perseus is a medical device that received FDA 510(k) clearance on 2020-09-09. It is manufactured by Orthokey Italia S.R.L.. The 510(k) number is K192653.

When was Perseus approved by the FDA?

Perseus received FDA 510(k) clearance on 2020-09-09, under approval number K192653.

What company makes Perseus?

Perseus is manufactured by Orthokey Italia S.R.L..

What is the FDA product code for Perseus?

The FDA product code for Perseus is OLO.

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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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