Cleared Traditional

CAT 10-NEUROLOGY DEVICE

K840314 · Imm Enterprises , Ltd. · Neurology
Feb 1984
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K840314 is an FDA 510(k) clearance for the CAT 10-NEUROLOGY DEVICE, a Percussor (Class I — General Controls, product code GWZ), submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1984, 30 days after receiving the submission on January 24, 1984. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1700.

Submission Details

510(k) Number K840314 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1984
Decision Date February 23, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GWZ — Percussor
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.1700

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