FDA 510(k)

迪奈雷克斯 Xeroform 煤焦油敷料

K 號：K152970 · 2016-10-03

決定日期2016-10-03

產品代碼FRO

決定相當於

器材摘要

Dynarex Xeroform Petrolatum Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corporation. It received FDA 510(k) clearance on 2016-10-03 under 510(k) number K152970. 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 Dynarex Xeroform Petrolatum Dressing?

Dynarex Xeroform Petrolatum Dressing is a medical device that received FDA 510(k) clearance on 2016-10-03. The listed applicant is Dynarex Corporation. The 510(k) number is K152970.

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

Dynarex Xeroform Petrolatum Dressing received FDA 510(k) clearance on 2016-10-03, under 510(k) number K152970.

Who is the listed applicant for Dynarex Xeroform Petrolatum Dressing?

The FDA 510(k) record lists Dynarex Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

其他以 Dynarex Corporation 為申請人之記錄

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K172266達能克斯三通針心

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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