FDA 510(k)

NaviNetics D1 穿刺系統

K 號：K210700 · 2021-06-17

決定日期2021-06-17

產品代碼HAW

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

NaviNetics D1 Stereotactic System is the device name listed in this FDA 510(k) record. The listed applicant is Navinetics, Inc.. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K210700. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NaviNetics D1 Stereotactic System?

NaviNetics D1 Stereotactic System is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Navinetics, Inc.. The 510(k) number is K210700.

When did NaviNetics D1 Stereotactic System receive FDA 510(k) clearance?

NaviNetics D1 Stereotactic System received FDA 510(k) clearance on 2021-06-17, under 510(k) number K210700.

Who is the listed applicant for NaviNetics D1 Stereotactic System?

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

What is the FDA product code for NaviNetics D1 Stereotactic System?

The FDA product code for NaviNetics D1 Stereotactic System is HAW.

其他以 Navinetics, Inc. 為申請人之記錄

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相關器械（代碼：HAW）

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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