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FDA 510(k)

VenusX

K-Number: K232489 · 2024-04-12

ApplicantLinatech, LLC
Decision Date2024-04-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VenusX is a medical device manufactured by Linatech, LLC. It received FDA 510(k) clearance on 2024-04-12 under approval number K232489. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VenusX?

VenusX is a medical device that received FDA 510(k) clearance on 2024-04-12. It is manufactured by Linatech, LLC. The 510(k) number is K232489.

When was VenusX approved by the FDA?

VenusX received FDA 510(k) clearance on 2024-04-12, under approval number K232489.

What company makes VenusX?

VenusX is manufactured by Linatech, LLC.

What is the FDA product code for VenusX?

The FDA product code for VenusX is IYE.

Related Devices (Code: IYE)

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.