Cleared Traditional

K823742 - NEUROMOD COMPLEMENT #7724 DUAL CHANNEL (FDA 510(k) Clearance)

Jan 1983
Decision
39d
Days
Class 2
Risk

K823742 is an FDA 510(k) clearance for the NEUROMOD COMPLEMENT #7724 DUAL CHANNEL. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on January 21, 1983, 39 days after receiving the submission on December 13, 1982.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K823742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1982
Decision Date January 21, 1983
Days to Decision 39 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary

Device Classification

Product Code GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.5890