Cleared Traditional

NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH

K822268 · Kelleher Corp. · Neurology
Jan 1983
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K822268 is an FDA 510(k) clearance for the NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983, 183 days after receiving the submission on July 29, 1982. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number K822268 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1982
Decision Date January 28, 1983
Days to Decision 183 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GWN — Nystagmograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1460