Cleared Traditional

K943066 - INTERACOUSTICS COMPUTER AUDIOMETER BA 20

K943066 is an FDA 510(k) clearance for INTERACOUSTICS COMPUTER AUDIOMETER BA 20, manufactured by Precision Acoustics Ind., Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K943066 · Precision Acoustics Ind., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
57d
Days
Class 2
Risk

K943066 is an FDA 510(k) clearance for the INTERACOUSTICS COMPUTER AUDIOMETER BA 20. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Precision Acoustics Ind., Inc. (New York, US). The FDA issued a Cleared decision on August 24, 1994 after a review of 57 days - a notably fast clearance cycle.

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: 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 Precision Acoustics Ind., Inc. devices

FDA 510(k) Submission Details - K943066

510(k) Number K943066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1994
Decision Date August 24, 1994
Days to Decision 57 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 89d · This submission: 57d
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 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K943066.
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K931322 · Maico Hearing Instruments, Inc. · Aug 1994
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K940216 · Beltone Electronics Corp. · Jul 1994
ODYSSEY CLINICAL AUDIOMETER
K935348 · Qualitone · Feb 1994