FDA 510(k)

Optimus 神經系統 - 無菌套件

K 號：K190811 · 2019-11-27

決定日期2019-11-27

產品代碼GWO

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

Optimus NEURO System - Sterile Kit is the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2019-11-27 under 510(k) number K190811. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Optimus NEURO System - Sterile Kit?

Optimus NEURO System - Sterile Kit is a medical device that received FDA 510(k) clearance on 2019-11-27. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K190811.

When did Optimus NEURO System - Sterile Kit receive FDA 510(k) clearance?

Optimus NEURO System - Sterile Kit received FDA 510(k) clearance on 2019-11-27, under 510(k) number K190811.

Who is the listed applicant for Optimus NEURO System - Sterile Kit?

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

What is the FDA product code for Optimus NEURO System - Sterile Kit?

The FDA product code for Optimus NEURO System - Sterile Kit is GWO.

其他以 Osteonic Co., Ltd. 為申請人之記錄

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