FDA 510(k)

BD ChloraShield I.V. 製片含 CHG 抗菌劑

K 號：K170407 · 2017-07-17

決定日期2017-07-17

產品代碼FRO

決定相當於

器材摘要

BD ChloraShield IV Dressing with CHG Antimicrobial is the device name listed in this FDA 510(k) record. The listed applicant is Avery Dennison Belgie Bvba. It received FDA 510(k) clearance on 2017-07-17 under 510(k) number K170407. 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 BD ChloraShield IV Dressing with CHG Antimicrobial?

BD ChloraShield IV Dressing with CHG Antimicrobial is a medical device that received FDA 510(k) clearance on 2017-07-17. The listed applicant is Avery Dennison Belgie Bvba. The 510(k) number is K170407.

When did BD ChloraShield IV Dressing with CHG Antimicrobial receive FDA 510(k) clearance?

BD ChloraShield IV Dressing with CHG Antimicrobial received FDA 510(k) clearance on 2017-07-17, under 510(k) number K170407.

Who is the listed applicant for BD ChloraShield IV Dressing with CHG Antimicrobial?

The FDA 510(k) record lists Avery Dennison Belgie Bvba as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD ChloraShield IV Dressing with CHG Antimicrobial?

The FDA product code for BD ChloraShield IV Dressing with CHG Antimicrobial is FRO. This falls under the Anesthesiology category.

其他以 Avery Dennison Belgie Bvba 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。

K202208BeneHold外科切口巾，含CHG抗菌劑

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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