免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

銅氧化物抗菌傷口敷料（MedCu ABWDs）

K 號：K180643 · 2018-11-23

申請人Medcu Technologies , Ltd.
決定日期2018-11-23
產品代碼FRO
決定相當於

器材摘要

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) is the device name listed in this FDA 510(k) record. The listed applicant is Medcu Technologies , Ltd.. It received FDA 510(k) clearance on 2018-11-23 under 510(k) number K180643. 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 MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)?

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) is a medical device that received FDA 510(k) clearance on 2018-11-23. The listed applicant is Medcu Technologies , Ltd.. The 510(k) number is K180643.

When did MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) receive FDA 510(k) clearance?

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) received FDA 510(k) clearance on 2018-11-23, under 510(k) number K180643.

Who is the listed applicant for MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)?

The FDA 510(k) record lists Medcu Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)?

The FDA product code for MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) 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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑