FDA 510(k)

六角星皮膚醫療設備規範文本

K 號：K171191 · 2017-08-25

決定日期2017-08-25

產品代碼FRO

決定相當於

器材摘要

Hexagen Derm is the device name listed in this FDA 510(k) record. The listed applicant is Global Health Solutions, LLC. It received FDA 510(k) clearance on 2017-08-25 under 510(k) 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.

常見問題

What is the Hexagen Derm?

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

When did Hexagen Derm receive FDA 510(k) clearance?

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

Who is the listed applicant for Hexagen Derm?

The FDA 510(k) record lists Global Health Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hexagen Derm?

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

其他以 Global Health Solutions, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K160872多聚膠 wound 裝飾

相關器械（代碼：FRO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254168Actolind® (06.3637. Actolind®膠漿)ACTO GmbH K254041皮膚智選抗菌濕凝膠Magic Science Supply, LLC K261646Redermax® 抗菌傷口組織Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLC K251929SilverCeuticals® 抗菌傷口膠Silverceuticals, Inc.K261023微達辛傷口灌洗溶液Sonoma Pharmaceuticals, Inc.

官方來源

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