FDA 510(k)

Atteris抗菌皮膚與創口清潔劑

K 號：K160192 · 2016-07-28

決定日期2016-07-28

產品代碼FRO

決定相當於

器材摘要

Atteris Antimicrobial Skin & Wound Cleanser is the device name listed in this FDA 510(k) record. The listed applicant is Rochal Industries, LLC. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K160192. 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 Atteris Antimicrobial Skin & Wound Cleanser?

Atteris Antimicrobial Skin & Wound Cleanser is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Rochal Industries, LLC. The 510(k) number is K160192.

When did Atteris Antimicrobial Skin & Wound Cleanser receive FDA 510(k) clearance?

Atteris Antimicrobial Skin & Wound Cleanser received FDA 510(k) clearance on 2016-07-28, under 510(k) number K160192.

Who is the listed applicant for Atteris Antimicrobial Skin & Wound Cleanser?

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

What is the FDA product code for Atteris Antimicrobial Skin & Wound Cleanser?

The FDA product code for Atteris Antimicrobial Skin & Wound Cleanser is FRO. This falls under the Anesthesiology category.

其他以 Rochal Industries, 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。

K192527羅查爾抗菌潤膚凝胶 K182733羅查生物防護矽膠薄膜 K161212Atteris抗菌皮膚保護劑 K160684Atteris No-Sting Skin Protectant

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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