Cleared Traditional

ToFscan

K172690 · Idmed · Anesthesiology

May 2018

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K172690 is an FDA 510(k) clearance for the ToFscan, a Stimulator, Nerve, Peripheral, Electric (Class II — Special Controls, product code KOI), submitted by Idmed (Marseille, FR). The FDA issued a Cleared decision on May 31, 2018, 267 days after receiving the submission on September 6, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2775.

Submission Details

510(k) Number	K172690 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 2017
Decision Date	May 31, 2018
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF