TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)— 510(k) K261098
Substantially EquivalentSenzime AB
FDA 510(k) clearance K261098 for TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017), Substantially Equivalent on 2026-05-22. Applicant: Senzime AB.
Clearance details
- Applicant
- Senzime AB
- Product code
- Code KOI
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Uppsala, SE
Data sourced from openFDA. This site is unofficial and independent of the FDA.