TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
Device Facts
| Record ID | K261098 |
|---|---|
| Device Name | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) |
| Applicant | Senzime AB |
| Product Code | KOI · Anesthesiology |
| Decision Date | May 22, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 868.2775 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.
