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FDA 510(k)

微克辛抗菌皮膚及傷口清潔劑

K 號：K172622 · 2017-11-21

申請人Sonoma Pharmaceuticals
決定日期2017-11-21
產品代碼FRO
決定相當於

器材摘要

Microcyn Antimicrobial Skin and Wound Cleanser is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Pharmaceuticals. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K172622. 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 Skin and Wound Cleanser?

Microcyn Antimicrobial Skin and Wound Cleanser is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Sonoma Pharmaceuticals. The 510(k) number is K172622.

When did Microcyn Antimicrobial Skin and Wound Cleanser receive FDA 510(k) clearance?

Microcyn Antimicrobial Skin and Wound Cleanser received FDA 510(k) clearance on 2017-11-21, under 510(k) number K172622.

Who is the listed applicant for Microcyn Antimicrobial Skin and Wound Cleanser?

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 Microcyn Antimicrobial Skin and Wound Cleanser?

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

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Sonoma Pharmaceuticals 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。

K171727Hydrocleanse 抗菌皮膚及傷口護理溶液

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 GmbHK254041皮膚智選抗菌濕凝膠Magic Science Supply, LLCK261646Redermax® 抗菌傷口組織Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLCK251929SilverCeuticals® 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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