Cleared Traditional

K922037 - SYSTEM 2000

K922037 · Micromedical Technologies, Inc. · Ear, Nose, Throat device
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Oct 1992
Decision
178d
Days
-
Risk

K922037 is an FDA 510(k) clearance for the SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Micromedical Technologies, Inc. (Chatham, US). The FDA issued a Cleared decision on October 26, 1992 after a review of 178 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 K922037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1992
Decision Date October 26, 1992
Days to Decision 178 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
89d slower than avg
Panel avg: 89d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -