Cleared Special

K992807 - BIO-LOGIC EVOKED POTENTIAL FOR ABAER I

K992807 is an FDA 510(k) clearance for BIO-LOGIC EVOKED POTENTIAL FOR ABAER I, 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 25-day FDA review.

K992807 · Bio-Logic Systems Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
25d
Days
Class 2
Risk

K992807 is an FDA 510(k) clearance for the BIO-LOGIC EVOKED POTENTIAL FOR ABAER I. 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 September 14, 1999 after a review of 25 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 - K992807

510(k) Number K992807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1999
Decision Date September 14, 1999
Days to Decision 25 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
123d faster than avg
Panel avg: 148d · This submission: 25d
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 21
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K992807.
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
K021895 · Bio-Logic Systems Corp. · Jul 2002
BIO-LOGIC ABAER CUB
K021215 · Bio-Logic Systems Corp. · May 2002
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K994149 · Bio-Logic Systems Corp. · Dec 1999
EXCEL AV STIM 1000
K972157 · Excel Tech. , Ltd. · Jan 1998
DANTEC COUNTERPOINT MK2(TM)
K913957 · Dantec Medical, Inc. · Jan 1992
TECA/MEDELEC AS-10 SENSOR
K862906 · Teca, Inc. · Feb 1987