Cleared Traditional

K833883 - DIGITAL AUDIOMETER/HEARING AID 3100

K833883 is an FDA 510(k) clearance for DIGITAL AUDIOMETER/HEARING AID 3100, manufactured by Frye Electronics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K833883 · Frye Electronics, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
104d
Days
Class 2
Risk

K833883 is an FDA 510(k) clearance for the DIGITAL AUDIOMETER/HEARING AID 3100. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Frye Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Frye Electronics, Inc. devices

FDA 510(k) Submission Details - K833883

510(k) Number K833883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1983
Decision Date February 21, 1984
Days to Decision 104 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
14d slower than avg
Panel avg: 90d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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.

Regulatory Peers - EWO Audiometer

All 114
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K833883.
MA25 PORTABLE AUDIOMETER
K853919 · Maico Hearing Instruments, Inc. · Dec 1985
UP800 A UNIVERSAL PRINTER
K845050 · Madsen Electronics (Canada) , Ltd. · May 1985
AUDIOMETER MA728
K841567 · Maico Hearing Instruments, Inc. · Jun 1984
THE SCREENING TYMPANOMETER
K822745 · American Electromedics Corp. · Sep 1982
PORTABLE AUDIOMETERS
K811727 · Maico Hearing Instruments, Inc. · Jul 1981
TINNITUS RESEARCH AUDIOMETER
K802560 · Starkey Laboratories, Inc. · Nov 1980