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FDA 510(k)

ALGS6 Ag 羧甲基鹽 wound dressing

K 號：K172570 · 2018-05-11

申請人Foshan United Medical Technologies, Ltd.
決定日期2018-05-11
產品代碼FRO
決定相當於

器材摘要

ALGS6 Ag Alginate Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Foshan United Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2018-05-11 under 510(k) number K172570. 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 ALGS6 Ag Alginate Wound Dressing?

ALGS6 Ag Alginate Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Foshan United Medical Technologies, Ltd.. The 510(k) number is K172570.

When did ALGS6 Ag Alginate Wound Dressing receive FDA 510(k) clearance?

ALGS6 Ag Alginate Wound Dressing received FDA 510(k) clearance on 2018-05-11, under 510(k) number K172570.

Who is the listed applicant for ALGS6 Ag Alginate Wound Dressing?

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

What is the FDA product code for ALGS6 Ag Alginate Wound Dressing?

The FDA product code for ALGS6 Ag Alginate 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

其他以 Foshan United Medical Technologies, Ltd. 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。

K233111ALGS2 Ag 羧甲基鹽 wound dressing Rx; ALGS2 Ag 羧甲基鹽 wound dressing OTC; ALGS2S 加強型 Ag 羧甲基鹽 wound dressing Rx; ALGS2S 加強型 Ag 羧甲基鹽 wound dressing OTC

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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