FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Neuromuscular Transmission Monitor TOF3D
K Number: K212434
·
Decision May 5, 2022
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
1
Review Days
274
Basic Information
- Device Name
- Neuromuscular Transmission Monitor TOF3D
- K Number
- K212434
- 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
- August 4, 2021
- Decision Date
- May 5, 2022
- 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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