Cleared Special

K994149 - MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.

K994149 is an FDA 510(k) clearance for MODIFICATION TO BIO-LOGIC EVOKED POTENT..., manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Neurology device with product code GWJ cleared through the Special 510(k) pathway after a 19-day FDA review.

K994149 · Bio-Logic Systems Corp. · Neurology device
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Dec 1999
Decision
19d
Days
Class 2
Risk

K994149 is an FDA 510(k) clearance for the MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mudelein, US). The FDA issued a Cleared decision on December 27, 1999 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K994149

510(k) Number K994149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1999
Decision Date December 27, 1999
Days to Decision 19 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 149d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

GWJ Device Classification - Class 2, Special Controls

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
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 - GWJ Stimulator, Auditory, Evoked Response

All 54
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K994149.
ALGO 3 NEWBORN HEARING SCREENER
K013137 · Natus Medical, Inc. · Oct 2001
MB 11
K011746 · Maico Diagnostic GmbH · Aug 2001
ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
K002985 · Ics Medical Corp. · Dec 2000
SABRE
K993177 · Sle Limited · Nov 1999
INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
K991853 · Idem (Int'L Dist. of Electronics For Medicine) · Oct 1999
BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
K992807 · Bio-Logic Systems Corp. · Sep 1999