FDA 510(k)

蒙特里斯醫療神經刀系統

K 號：K240877 · 2024-06-04

決定日期2024-06-04

產品代碼ONO

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Monteris Medical NeuroBlate System is the device name listed in this FDA 510(k) record. The listed applicant is Monteris Medical,. It received FDA 510(k) clearance on 2024-06-04 under 510(k) number K240877. The device is classified under product code ONO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Monteris Medical NeuroBlate System?

Monteris Medical NeuroBlate System is a medical device that received FDA 510(k) clearance on 2024-06-04. The listed applicant is Monteris Medical,. The 510(k) number is K240877.

When did Monteris Medical NeuroBlate System receive FDA 510(k) clearance?

Monteris Medical NeuroBlate System received FDA 510(k) clearance on 2024-06-04, under 510(k) number K240877.

Who is the listed applicant for Monteris Medical NeuroBlate System?

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

What is the FDA product code for Monteris Medical NeuroBlate System?

The FDA product code for Monteris Medical NeuroBlate System is ONO.

其他以 Monteris Medical, 為申請人之記錄

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相關器械（代碼：ONO）

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。

K262315神經消融系統Monteris Medical K260976神經消融系統Monteris Medical K253391視覺熱激光應用器系統 (9735559)；視覺熱激光應用器系統 (9735560)；視覺熱激光應用器系統 (9735561)Medtronic Navigation, Inc.K251298移動雷射單元（1001-N2）；熱導工作站（1100-N1）；雷射施用器（4012-N5、4017-N2、4017-N4）；MR 引導器（4013-N6）Clinical Laserthermia Systems, AB K250307視覺化V2 MRI導引激光消融系統（9736422）Medtronic Navigation K214125TRANBERG 體溫導引治療系統Clinical Laserthermia Systems, AB

官方來源

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