FDA 510(k)

Hydrocleanse 抗菌皮膚及傷口護理溶液

K 號：K171727 · 2017-07-26

決定日期2017-07-26

產品代碼FRO

決定相當於

器材摘要

Hydrocleanse Antimicrobial Skin and Wound Care Solution is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Pharmaceuticals. It received FDA 510(k) clearance on 2017-07-26 under 510(k) number K171727. 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 Hydrocleanse Antimicrobial Skin and Wound Care Solution?

Hydrocleanse Antimicrobial Skin and Wound Care Solution is a medical device that received FDA 510(k) clearance on 2017-07-26. The listed applicant is Sonoma Pharmaceuticals. The 510(k) number is K171727.

When did Hydrocleanse Antimicrobial Skin and Wound Care Solution receive FDA 510(k) clearance?

Hydrocleanse Antimicrobial Skin and Wound Care Solution received FDA 510(k) clearance on 2017-07-26, under 510(k) number K171727.

Who is the listed applicant for Hydrocleanse Antimicrobial Skin and Wound Care Solution?

The FDA 510(k) record lists Sonoma Pharmaceuticals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hydrocleanse Antimicrobial Skin and Wound Care Solution?

The FDA product code for Hydrocleanse Antimicrobial Skin and Wound Care Solution is FRO. This falls under the Anesthesiology category.

其他以 Sonoma Pharmaceuticals 為申請人之記錄

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K172622微克辛抗菌皮膚及傷口清潔劑

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。

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官方來源

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