K261098
- 510(k) number
- 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 SE
- Product code
- KOI — Stimulator, Nerve, Peripheral, Electric
- Decision date
- 2026-05-22
- Date received
- 2026-04-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K261098.pdf
Official FDA record: K261098
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.