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FDA 510(k)

防護抗菌傷口敷料

K 號：K183681 · 2019-10-11

申請人Global Health Solutions (Dba Turn Therapeutics)
決定日期2019-10-11
產品代碼FRO
決定相當於

器材摘要

Protego Antimicrobial Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Global Health Solutions (Dba Turn Therapeutics). It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K183681. 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 Protego Antimicrobial Wound Dressing?

Protego Antimicrobial Wound Dressing is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Global Health Solutions (Dba Turn Therapeutics). The 510(k) number is K183681.

When did Protego Antimicrobial Wound Dressing receive FDA 510(k) clearance?

Protego Antimicrobial Wound Dressing received FDA 510(k) clearance on 2019-10-11, under 510(k) number K183681.

Who is the listed applicant for Protego Antimicrobial Wound Dressing?

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

What is the FDA product code for Protego Antimicrobial Wound Dressing?

The FDA product code for Protego Antimicrobial Wound Dressing 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

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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