Tetragraph Neuromuscular Transmission Monitor— 510(k) K190795
Substantially EquivalentSenzime AB
FDA 510(k) clearance K190795 for Tetragraph Neuromuscular Transmission Monitor, Substantially Equivalent on 2019-10-18. Applicant: Senzime AB. Device class: 2.
Clearance details
- Applicant
- Senzime AB
- Product code
- Code KOI
- Device class
- Class 2
- Regulation
- 21 CFR 868.2775
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
Recent devices under product code KOI
view all- K261098 — TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
- K250887 — Neuromuscular Transmission Monitor TOF3D (2510091)
- K243339 — WiTOF
- K242525 — iTOF®
- K220530 — Tetragraph Neuromuscular Transmission Monitor
Data sourced from openFDA. This site is unofficial and independent of the FDA.