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FDA 510(k)

Hexagen Derm

K-Number: K171191 · 2017-08-25

ApplicantGlobal Health Solutions, LLC
Decision Date2017-08-25
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Hexagen Derm is a medical device manufactured by Global Health Solutions, LLC. It received FDA 510(k) clearance on 2017-08-25 under approval number K171191. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hexagen Derm?

Hexagen Derm is a medical device that received FDA 510(k) clearance on 2017-08-25. It is manufactured by Global Health Solutions, LLC. The 510(k) number is K171191.

When was Hexagen Derm approved by the FDA?

Hexagen Derm received FDA 510(k) clearance on 2017-08-25, under approval number K171191.

What company makes Hexagen Derm?

Hexagen Derm is manufactured by Global Health Solutions, LLC.

What is the FDA product code for Hexagen Derm?

The FDA product code for Hexagen Derm is FRO. This falls under the Anesthesiology category.

Other Devices by Global Health Solutions, LLC

K160872PolyPlex Wound Dressing

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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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