FDA 510(k)

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K 號：K203773 · 2022-01-14

決定日期2022-01-14

產品代碼HWC

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器材摘要

BRM TOOL Screws is the device name listed in this FDA 510(k) record. The listed applicant is Brm Extremities Srl. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K203773. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the BRM TOOL Screws?

BRM TOOL Screws is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Brm Extremities Srl. The 510(k) number is K203773.

When did BRM TOOL Screws receive FDA 510(k) clearance?

BRM TOOL Screws received FDA 510(k) clearance on 2022-01-14, under 510(k) number K203773.

Who is the listed applicant for BRM TOOL Screws?

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

What is the FDA product code for BRM TOOL Screws?

The FDA product code for BRM TOOL Screws is HWC. This falls under the Cardiovascular category.

其他以 Brm Extremities Srl 為申請人之記錄

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相關器械（代碼：HWC）

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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