Cleared Traditional

NEURO PULSE

K841400 · Parker Laboratories, Inc. · Neurology
Jun 1984
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K841400 is an FDA 510(k) clearance for the NEURO PULSE, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1984, 73 days after receiving the submission on April 3, 1984. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K841400 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1984
Decision Date June 15, 1984
Days to Decision 73 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

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