FDA 510(k)

羅斯因 Xeroform 煤焦油敷料

K 號：K181478 · 2019-09-13

決定日期2019-09-13

產品代碼FRO

決定相當於

器材摘要

Roosin Xeroform Petrolatum Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Roosin Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K181478. 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 Roosin Xeroform Petrolatum Dressing?

Roosin Xeroform Petrolatum Dressing is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Roosin Medical Co., Ltd.. The 510(k) number is K181478.

When did Roosin Xeroform Petrolatum Dressing receive FDA 510(k) clearance?

Roosin Xeroform Petrolatum Dressing received FDA 510(k) clearance on 2019-09-13, under 510(k) number K181478.

Who is the listed applicant for Roosin Xeroform Petrolatum Dressing?

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

What is the FDA product code for Roosin Xeroform Petrolatum Dressing?

The FDA product code for Roosin Xeroform Petrolatum Dressing is FRO. This falls under the Anesthesiology category.

其他以 Roosin Medical Co., 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。

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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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