Cleared Traditional

Tech Dots - Adhesive and conductive gel

K190050 · Spes Medica Srl · Neurology
Jul 2019
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K190050 is an FDA 510(k) clearance for the Tech Dots - Adhesive and conductive gel, a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Spes Medica Srl (Battipaglia (Sa), IT). The FDA issued a Cleared decision on July 19, 2019, 190 days after receiving the submission on January 10, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number K190050 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2019
Decision Date July 19, 2019
Days to Decision 190 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GYB — Media, Electroconductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1275