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FDA 510(k)

VirtueRF

K-Number: K202415 · 2021-01-22

Decision Date2021-01-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VirtueRF is the device name listed in this FDA 510(k) record. The listed applicant is ShenB Co., Ltd.. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K202415. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VirtueRF?

VirtueRF is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is ShenB Co., Ltd.. The 510(k) number is K202415.

When did VirtueRF receive FDA 510(k) clearance?

VirtueRF received FDA 510(k) clearance on 2021-01-22, under 510(k) number K202415.

Who is the listed applicant for VirtueRF?

The FDA 510(k) record lists ShenB Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VirtueRF?

The FDA product code for VirtueRF is GEI.

Other records listing ShenB Co., Ltd. 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.

View all 11 devices →

Related Devices (Code: GEI)

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.

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.