FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Neuromuscular Transmission Monitor TOF3D (2510091)
K Number: K250887
·
Decision Oct 21, 2025
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
28
Applicant Total
2
Review Days
210
Basic Information
- Device Name
- Neuromuscular Transmission Monitor TOF3D (2510091)
- K Number
- K250887
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Date Received
- March 25, 2025
- Decision Date
- October 21, 2025
- Product Code
- KOI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KOI | Stimulator, Nerve, Peripheral, Electric | FDA class 2 | Anesthesiology |
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Other Clearances by MIPM Mammendorfer Institut für Physik und Medizin GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K212434 | Neuromuscular Transmission Monitor TOF3D | May 5, 2022 | Substantially Equivalent |