FDA 510(k)

神经肌肉传导监测器TOF3D (2510091)

K号: K250887 · 2025-10-21

申请人MIPM Mammendorfer Institut für Physik und Medizin GmbH

决定日期2025-10-21

产品代码KOI

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Neuromuscular Transmission Monitor TOF3D (2510091) 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 2025-10-21 under 510(k) number K250887. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Neuromuscular Transmission Monitor TOF3D (2510091)?

Neuromuscular Transmission Monitor TOF3D (2510091) is a medical device that received FDA 510(k) clearance on 2025-10-21. The listed applicant is MIPM Mammendorfer Institut für Physik und Medizin GmbH. The 510(k) number is K250887.

When did Neuromuscular Transmission Monitor TOF3D (2510091) receive FDA 510(k) clearance?

Neuromuscular Transmission Monitor TOF3D (2510091) received FDA 510(k) clearance on 2025-10-21, under 510(k) number K250887.

Who is the listed applicant for Neuromuscular Transmission Monitor TOF3D (2510091)?

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 (2510091)?

The FDA product code for Neuromuscular Transmission Monitor TOF3D (2510091) is KOI.

列明MIPM Mammendorfer Institut für Physik und Medizin GmbH为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K212434神经肌肉传导监测器TOF3D

官方来源

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