FDA 510(k)

碘柔膠

K 號：K190756 · 2019-12-20

決定日期2019-12-20

產品代碼FRO

決定相當於

器材摘要

IODOFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K190756. 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 IODOFLEX?

IODOFLEX is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K190756.

When did IODOFLEX receive FDA 510(k) clearance?

IODOFLEX received FDA 510(k) clearance on 2019-12-20, under 510(k) number K190756.

Who is the listed applicant for IODOFLEX?

FDA 510(k) 記錄將史密斯與內夫公司（Smith & Nephew Medical, Ltd.）列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for IODOFLEX?

The FDA product code for IODOFLEX is FRO. This falls under the Anesthesiology category.

其他以 Smith & Nephew Medical, Ltd. 為申請人之記錄

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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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