Cleared Traditional

NEMECTRODYN MODELS 8,7,5 (VOLS. I-IV (K820334) - FDA 510(k) Clearance

K820334 · Nemectron Medical, Inc. · Neurology device
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Mar 1982
Decision
38d
Days
-
Risk

K820334 is an FDA 510(k) clearance for the NEMECTRODYN MODELS 8,7,5 (VOLS. I-IV.

Submitted by Nemectron Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1982 after a review of 38 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nemectron Medical, Inc. devices

Submission Details

510(k) Number K820334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1982
Decision Date March 15, 1982
Days to Decision 38 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 148d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -