Cleared Traditional

K843464 - SIEGEN NEUROSCOPE

K843464 is the FDA 510(k) clearance for SIEGEN NEUROSCOPE by Siegen Corp.. It is a Class 2 Neurology device (product code GWF) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K843464 · Siegen Corp. · Neurology device
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Nov 1984
Decision
76d
Days
Class 2
Risk

K843464 is an FDA 510(k) clearance for the SIEGEN NEUROSCOPE. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Siegen Corp. (Mountain View, US). The FDA issued a Cleared decision on November 20, 1984 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology device framework. 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 Siegen Corp. devices

Submission Details

510(k) Number K843464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1984
Decision Date November 20, 1984
Days to Decision 76 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 148d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWF Stimulator, Electrical, Evoked Response

All 51
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K843464.
BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM
K844992 · Bio-Logic Systems Corp. · Jun 1985
QUANTUM 84
K844707 · Cadwell Laboratories, Inc. · May 1985
EVOKED POTENTIAL SYS
K842543 · Bio-Logic Systems Corp. · Nov 1984
CADWELL 8400
K830771 · Cadwell Laboratories, Inc. · Apr 1983
CADWELL 7400
K822214 · Cadwell Laboratories, Inc. · Sep 1982