FDA 510(k)

Vertos mild Device Kit (MDK-0002)

K-Number: K233800 · 2024-05-06

Decision Date2024-05-06

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Vertos mild Device Kit (MDK-0002) is a medical device manufactured by Vertos Medical, Inc.. It received FDA 510(k) clearance on 2024-05-06 under approval number K233800. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vertos mild Device Kit (MDK-0002)?

Vertos mild Device Kit (MDK-0002) is a medical device that received FDA 510(k) clearance on 2024-05-06. It is manufactured by Vertos Medical, Inc.. The 510(k) number is K233800.

When was Vertos mild Device Kit (MDK-0002) approved by the FDA?

Vertos mild Device Kit (MDK-0002) received FDA 510(k) clearance on 2024-05-06, under approval number K233800.

What company makes Vertos mild Device Kit (MDK-0002)?

Vertos mild Device Kit (MDK-0002) is manufactured by Vertos Medical, Inc..

What is the FDA product code for Vertos mild Device Kit (MDK-0002)?

The FDA product code for Vertos mild Device Kit (MDK-0002) is HRX.

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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.