Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

V12 PRO

K-Number: K210913 · 2021-08-04

Decision Date2021-08-04
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

V12 PRO is a medical device manufactured by Slk Medical GmbH. It received FDA 510(k) clearance on 2021-08-04 under approval number K210913. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V12 PRO?

V12 PRO is a medical device that received FDA 510(k) clearance on 2021-08-04. It is manufactured by Slk Medical GmbH. The 510(k) number is K210913.

When was V12 PRO approved by the FDA?

V12 PRO received FDA 510(k) clearance on 2021-08-04, under approval number K210913.

What company makes V12 PRO?

V12 PRO is manufactured by Slk Medical GmbH.

What is the FDA product code for V12 PRO?

The FDA product code for V12 PRO is IRP.

Other Devices by Slk Medical GmbH

Related Devices (Code: IRP)

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.