FDA 510(k)

Neuromuscular Transmission Monitor TOF3D

K-번호: K212434 · 2022-05-05

신청자MIPM Mammendorfer Institut für Physik und Medizin GmbH

결정일2022-05-05

제품 코드KOI

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

MIPM Mammendorfer Institut für Physik und Medizin GmbH를 신청인으로 등재한 기타 기록

K250887Neuromuscular Transmission Monitor TOF3D (2510091)

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