Cleared Traditional

GLOTTAL FREQUENCY ANALYSER

K841832 · Teltec Electronic Equipment AB · Ear, Nose, Throat
Jul 1984
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K841832 is an FDA 510(k) clearance for the GLOTTAL FREQUENCY ANALYSER, a Electroglottograph (Class II — Special Controls, product code KLX), submitted by Teltec Electronic Equipment AB (Mchenry, US). The FDA issued a Cleared decision on July 18, 1984, 76 days after receiving the submission on May 3, 1984. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1325.

Submission Details

510(k) Number K841832 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1984
Decision Date July 18, 1984
Days to Decision 76 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