Cleared Traditional

KILOWIN

K971214 · Cadwell Laboratories, Inc. · Neurology
Jun 1998
Decision
435d
Days
Class 2
Risk

About This 510(k) Submission

K971214 is an FDA 510(k) clearance for the KILOWIN, a Stimulator, Photic, Evoked Response (Class II — Special Controls, product code GWE), submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on June 11, 1998, 435 days after receiving the submission on April 2, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1890.

Submission Details

510(k) Number K971214 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1997
Decision Date June 11, 1998
Days to Decision 435 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GWE — Stimulator, Photic, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1890