Cleared Traditional

K930328 - NAVIGATOR & TRAVELER EVOKED POSTENTIAL ...

K930328 is an FDA 510(k) clearance for NAVIGATOR & TRAVELER EVOKED POSTENTIAL ..., manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K930328 · Bio-Logic Systems Corp. · Neurology device
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Jul 1993
Decision
161d
Days
Class 2
Risk

K930328 is an FDA 510(k) clearance for the NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mudelein, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 161 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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: 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 Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K930328

510(k) Number K930328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1993
Decision Date July 02, 1993
Days to Decision 161 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 148d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 22
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K930328.
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K880573 · Nicolet Biomedical Instruments · Mar 1988