Cleared Traditional

ANGIOSCANE SPECTRUM ANALYZER (K834501) - FDA 510(k) Clearance

K834501 · Unigon Industries, Inc. · Neurology device
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May 1984
Decision
154d
Days
-
Risk

K834501 is an FDA 510(k) clearance for the ANGIOSCANE SPECTRUM ANALYZER.

Submitted by Unigon Industries, Inc. (Walker, US). The FDA issued a Cleared decision on May 23, 1984 after a review of 154 days - an extended review cycle.

This device falls under the Neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Unigon Industries, Inc. devices

Submission Details

510(k) Number K834501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date May 23, 1984
Days to Decision 154 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 148d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -