Cleared Traditional

LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL

K933804 · Cadwell Laboratories, Inc. · Neurology
Mar 1994
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K933804 is an FDA 510(k) clearance for the LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL, a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on March 22, 1994, 230 days after receiving the submission on August 4, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number K933804 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1993
Decision Date March 22, 1994
Days to Decision 230 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