Cleared Traditional

ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG

K821079 · Ms. Kate Teaney · Ear, Nose, Throat
May 1982
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K821079 is an FDA 510(k) clearance for the ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG, a Electroglottograph (Class II — Special Controls, product code KLX), submitted by Ms. Kate Teaney (Walker, US). The FDA issued a Cleared decision on May 10, 1982, 21 days after receiving the submission on April 19, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1325.

Submission Details

510(k) Number K821079 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1982
Decision Date May 10, 1982
Days to Decision 21 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