510(k) K250887
K250887 is an FDA 510(k) premarket notification submitted by MIPM Mammendorfer Institut für Physik und Medizin GmbH for the device "Neuromuscular Transmission Monitor TOF3D (2510091)". The FDA issued a decision of Substantially Equivalent on October 21, 2025. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775. MIPM Mammendorfer Institut für Physik und Medizin GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2025
- Date Received
- March 25, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Peripheral, Electric
- Device Class
- Class II
- Regulation Number
- 868.2775
- Review Panel
- AN
- Submission Type