Tof-Guard Transmission Monitor
510(k) K925159
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925159 | Date1 Sep 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KOI
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2775
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Tof-Guard Transmission Monitor is a peripheral electric nerve stimulator. It is designed to provide neuromuscular transmission monitoring.
This device is classified as a Class 2 medical device under regulation 868.2775. It has received FDA 510(k) clearance under the reference number K925159.
Other devices from Biometer Intl. A/S
Questions
AI-generated answers, 22 Sep 2026
What is the primary function of the Tof-Guard Transmission Monitor?
The Tof-Guard Transmission Monitor is a peripheral electric nerve stimulator. It is specifically designed to provide neuromuscular transmission monitoring for patients.
What is the regulatory classification of this device?
The Tof-Guard Transmission Monitor is classified as a Class 2 medical device under regulation 868.2775. It has received FDA 510(k) clearance under the reference number K925159.
Which medical specialty is this device associated with?
This device is associated with the anesthesiology medical specialty, as indicated by its classification under the anesthesiology advisory committee.