TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)— 510(k) K261098

Name: FDA 510(k) clearance K261098
Creator: U.S. Food and Drug Administration
Published: 2026-05-22

Substantially Equivalent

Senzime 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. 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: 2026-04-02
Decision date: 2026-05-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.