510(k) K261098
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) by
Senzime AB
— Product Code KOI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2026
- Date Received
- April 2, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Peripheral, Electric
- Device Class
- Class II
- Regulation Number
- 868.2775
- Review Panel
- AN
- Submission Type