Clearance Summary
Neuromuscular Transmission Monitor TOF3D received FDA 510(k) clearance under submission number K212434, sponsored by MIPM Mammendorfer Institut für Physik und Medizin GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2022-05-05.
- Submission: K212434
- Applicant / Sponsor: MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2775
- Decision date: 2022-05-05
Classification & Regulation
This clearance is catalogued under FDA product code KOI and 21 CFR 868.2775, within the Anesthesiology review panel as a Class II device.