FDA 510(k)

新普系統

K 號：K191966 · 2020-02-13

決定日期2020-02-13

產品代碼KWH

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決定相當於

器材摘要

NewPrim System is the device name listed in this FDA 510(k) record. The listed applicant is Brm Extremities. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K191966. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NewPrim System?

NewPrim System is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is Brm Extremities. The 510(k) number is K191966.

When did NewPrim System receive FDA 510(k) clearance?

NewPrim System received FDA 510(k) clearance on 2020-02-13, under 510(k) number K191966.

Who is the listed applicant for NewPrim System?

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

What is the FDA product code for NewPrim System?

The FDA product code for NewPrim System is KWH.

其他以 Brm Extremities 為申請人之記錄

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相關器械（代碼：KWH）

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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