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FDA 510(k)

Vertos mild Device Kit (MDK-0002)

K-Number: K233800 · 2024-05-06

ApplicantVertos Medical, Inc.
Decision Date2024-05-06
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vertos mild Device Kit (MDK-0002) is the device name listed in this FDA 510(k) record. The listed applicant is Vertos Medical, Inc.. It received FDA 510(k) clearance on 2024-05-06 under 510(k) 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. The listed applicant is Vertos Medical, Inc.. The 510(k) number is K233800.

When did Vertos mild Device Kit (MDK-0002) receive FDA 510(k) clearance?

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

Who is the listed applicant for Vertos mild Device Kit (MDK-0002)?

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

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

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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