Cleared Traditional

K841832 - GLOTTAL FREQUENCY ANALYSER

K841832 is an FDA 510(k) clearance for GLOTTAL FREQUENCY ANALYSER, manufactured by Teltec Electronic Equipment AB. The device is a Class 2 Ear, Nose, Throat device with product code KLX cleared through the Traditional 510(k) pathway after a 76-day FDA review.

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

K841832 is an FDA 510(k) clearance for the GLOTTAL FREQUENCY ANALYSER. Classified as Electroglottograph (product code KLX), Class II - Special Controls.

Submitted by Teltec Electronic Equipment AB (Mchenry, US). The FDA issued a Cleared decision on July 18, 1984 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1325 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Teltec Electronic Equipment AB devices

FDA 510(k) Submission Details - K841832

510(k) Number K841832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 89d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLX Device Classification - Class 2, Special Controls

Product Code KLX Electroglottograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1325
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.