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FDA 510(k)

V12 PRO

K-Number: K210913 · 2021-08-04

ApplicantSlk Medical GmbH
Decision Date2021-08-04
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

V12 PRO is the device name listed in this FDA 510(k) record. The listed applicant is Slk Medical GmbH. It received FDA 510(k) clearance on 2021-08-04 under 510(k) 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. The listed applicant is Slk Medical GmbH. The 510(k) number is K210913.

When did V12 PRO receive FDA 510(k) clearance?

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

Who is the listed applicant for V12 PRO?

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

What is the FDA product code for V12 PRO?

The FDA product code for V12 PRO is IRP.

Other records listing Slk Medical GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193476VariLymph 12 pro

Related Devices (Code: IRP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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