Cleared Traditional

NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX (K934483) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K934483 · Mountain Precision Mfg. Ltd. Co. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
183d
Days
Class 1
Risk

K934483 is an FDA 510(k) clearance for the NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX. Classified as Larynx, Artificial (battery-powered) (product code ESE), Class I - General Controls.

Submitted by Mountain Precision Mfg. Ltd. Co. (Boise, US). The FDA issued a Cleared decision on March 16, 1994 after a review of 183 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3375 - 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 Mountain Precision Mfg. Ltd. Co. devices

Submission Details

510(k) Number K934483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1993
Decision Date March 16, 1994
Days to Decision 183 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
94d slower than avg
Panel avg: 89d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ESE Larynx, Artificial (battery-powered)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.