TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
FDA 510(k) clearance K261098 · decided 2026-05-22
Clearance details
- 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
- Decision
- Substantially Equivalent
- Date received
- 2026-04-02
- Decision date
- 2026-05-22
- Days to decision
- 50 days
- Clearance type
- Special
- Product code
- KOI
- Device class
- 2
- Regulation number
- 868.2775
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.