Cleared Traditional

MTA 86 (K844592) - FDA 510(k) Clearance

K844592 · Madsen Electronics (Canada) , Ltd. · Neurology device
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May 1985
Decision
177d
Days
-
Risk

K844592 is an FDA 510(k) clearance for the MTA 86.

Submitted by Madsen Electronics (Canada) , Ltd. (Oakville, Ontario, CA). The FDA issued a Cleared decision on May 22, 1985 after a review of 177 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 Madsen Electronics (Canada) , Ltd. devices

Submission Details

510(k) Number K844592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1984
Decision Date May 22, 1985
Days to Decision 177 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 148d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -