FDA 510(k)

BRM數位化間隔器

K 號：K220142 · 2023-04-04

決定日期2023-04-04

產品代碼KYJ

諮詢委員會或

決定相當於

器材摘要

BRM Digitalis Spacer 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 2023-04-04 under 510(k) number K220142. The device is classified under product code KYJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BRM Digitalis Spacer?

BRM Digitalis Spacer is a medical device that received FDA 510(k) clearance on 2023-04-04. The listed applicant is Brm Extremities Srl. The 510(k) number is K220142.

When did BRM Digitalis Spacer receive FDA 510(k) clearance?

BRM Digitalis Spacer received FDA 510(k) clearance on 2023-04-04, under 510(k) number K220142.

Who is the listed applicant for BRM Digitalis Spacer?

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 Digitalis Spacer?

The FDA product code for BRM Digitalis Spacer is KYJ.

其他以 Brm Extremities Srl 為申請人之記錄

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K203773BRM 工具螺釘

相關器械（代碼：KYJ）

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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