FDA 510(k)

微克辛抗菌水凝胶

K 號：K173896 · 2018-04-02

決定日期2018-04-02

產品代碼FRO

決定相當於

器材摘要

Microcyn Antimicrobial Hydrogel is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2018-04-02 under 510(k) number K173896. 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 Microcyn Antimicrobial Hydrogel?

Microcyn Antimicrobial Hydrogel is a medical device that received FDA 510(k) clearance on 2018-04-02. The listed applicant is Sonoma Pharmaceuticals, Inc.. The 510(k) number is K173896.

When did Microcyn Antimicrobial Hydrogel receive FDA 510(k) clearance?

Microcyn Antimicrobial Hydrogel received FDA 510(k) clearance on 2018-04-02, under 510(k) number K173896.

Who is the listed applicant for Microcyn Antimicrobial Hydrogel?

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

What is the FDA product code for Microcyn Antimicrobial Hydrogel?

The FDA product code for Microcyn Antimicrobial Hydrogel is FRO. This falls under the Anesthesiology category.

其他以 Sonoma Pharmaceuticals, Inc. 為申請人之記錄

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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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