FDA 510(k)

神經肌肉傳導監測器 TOF3D

K 號：K212434 · 2022-05-05

申請人MIPM Mammendorfer Institut für Physik und Medizin GmbH

決定日期2022-05-05

產品代碼KOI

諮詢委員會AN

決定相當於

器材摘要

Neuromuscular Transmission Monitor TOF3D is the device name listed in this FDA 510(k) record. The listed applicant is MIPM Mammendorfer Institut für Physik und Medizin GmbH. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K212434. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neuromuscular Transmission Monitor TOF3D?

Neuromuscular Transmission Monitor TOF3D is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is MIPM Mammendorfer Institut für Physik und Medizin GmbH. The 510(k) number is K212434.

When did Neuromuscular Transmission Monitor TOF3D receive FDA 510(k) clearance?

Neuromuscular Transmission Monitor TOF3D received FDA 510(k) clearance on 2022-05-05, under 510(k) number K212434.

Who is the listed applicant for Neuromuscular Transmission Monitor TOF3D?

The FDA 510(k) record lists MIPM Mammendorfer Institut für Physik und Medizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neuromuscular Transmission Monitor TOF3D?

The FDA product code for Neuromuscular Transmission Monitor TOF3D is KOI.

其他以 MIPM Mammendorfer Institut für Physik und Medizin GmbH 為申請人之記錄

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。

K250887神經肌肉傳導監測器 TOF3D (2510091)

相關器械（代碼：KOI）

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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官方來源

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