Cleared Traditional

MONOTRODE CUTANEOUS ELECTRODE

K915864 · Henley Intl. · Neurology
Jul 1993
Decision
568d
Days
Class 2
Risk

About This 510(k) Submission

K915864 is an FDA 510(k) clearance for the MONOTRODE CUTANEOUS ELECTRODE, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on July 21, 1993, 568 days after receiving the submission on December 31, 1991. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K915864 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1991
Decision Date July 21, 1993
Days to Decision 568 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1320

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