FDA 510(k)

BRM TOOL ツールボルト

K番号: K203773 · 2022-01-14

決定日2022-01-14

製品コードHWC

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてBrm Extremities Srlを記載するその他の記録

K220142BRMデジタリススペーサー

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。