Cleared Traditional

Tetragraph Neuromuscular Transmission Monitor

K220530 · Senzime AB · Anesthesiology

Aug 2022

Decision

174d

Days

Class 2

Risk

About This 510(k) Submission

K220530 is an FDA 510(k) clearance for the Tetragraph Neuromuscular Transmission Monitor, a Stimulator, Nerve, Peripheral, Electric (Class II — Special Controls, product code KOI), submitted by Senzime AB (Uppsala, SE). The FDA issued a Cleared decision on August 17, 2022, 174 days after receiving the submission on February 24, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2775.

Submission Details

510(k) Number	K220530 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2022
Decision Date	August 17, 2022
Days to Decision	174 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF