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FDA 510(k)

VirtuOst

K-Number: K220402 · 2023-05-19

ApplicantO.N. Diagnostics
Decision Date2023-05-19
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VirtuOst is a medical device manufactured by O.N. Diagnostics. It received FDA 510(k) clearance on 2023-05-19 under approval number K220402. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VirtuOst?

VirtuOst is a medical device that received FDA 510(k) clearance on 2023-05-19. It is manufactured by O.N. Diagnostics. The 510(k) number is K220402.

When was VirtuOst approved by the FDA?

VirtuOst received FDA 510(k) clearance on 2023-05-19, under approval number K220402.

What company makes VirtuOst?

VirtuOst is manufactured by O.N. Diagnostics.

What is the FDA product code for VirtuOst?

The FDA product code for VirtuOst is KGI.

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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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