Cleared Traditional

ELECTROGLOTTOGRAPH

K990240 · Kay Elemetrics Corp. · Ear, Nose, Throat
Mar 1999
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K990240 is an FDA 510(k) clearance for the ELECTROGLOTTOGRAPH, a Electroglottograph (Class II — Special Controls, product code KLX), submitted by Kay Elemetrics Corp. (Lincoln Park, US). The FDA issued a Cleared decision on March 11, 1999, 45 days after receiving the submission on January 25, 1999. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1325.

Submission Details

510(k) Number K990240 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1999
Decision Date March 11, 1999
Days to Decision 45 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code KLX — Electroglottograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1325