Cleared Traditional

SAC2 - Electrode Cream

K192606 · Spes Medica Srl · Neurology
Jan 2020
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K192606 is an FDA 510(k) clearance for the SAC2 - Electrode Cream, 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 January 17, 2020, 119 days after receiving the submission on September 20, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number K192606 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2019
Decision Date January 17, 2020
Days to Decision 119 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