Cleared Traditional

MODEL 322 CLINICAL AUDIOMETER (K930203) - FDA 510(k) Clearance

K930203 · Virtual Corp. · Ear, Nose, Throat device
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Jul 1993
Decision
175d
Days
-
Risk

K930203 is an FDA 510(k) clearance for the MODEL 322 CLINICAL AUDIOMETER. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Virtual Corp. (Portland, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 175 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel. 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.

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Submission Details

510(k) Number K930203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1993
Decision Date July 08, 1993
Days to Decision 175 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 89d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EWD Protector, Hearing (insert)
Device Class -