Cleared Traditional

ELECTROGLOTTOGRAPH

K901609 · Glottal Ent., Inc. · Ear, Nose, Throat
Jun 1990
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K901609 is an FDA 510(k) clearance for the ELECTROGLOTTOGRAPH, a Electroglottograph (Class II — Special Controls, product code KLX), submitted by Glottal Ent., Inc. (Washington, US). The FDA issued a Cleared decision on June 28, 1990, 83 days after receiving the submission on April 6, 1990. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1325.

Submission Details

510(k) Number K901609 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 1990
Decision Date June 28, 1990
Days to Decision 83 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

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