Cleared Traditional

UNIVERSAL TESTING & ANALYSIS SYSTEMS

K820414 · Lkc Technologies, Inc. · Neurology
Mar 1982
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K820414 is an FDA 510(k) clearance for the UNIVERSAL TESTING & ANALYSIS SYSTEMS, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Lkc Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1982, 20 days after receiving the submission on February 12, 1982. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K820414 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1982
Decision Date March 04, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GWF — Stimulator, Electrical, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1870

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