Cleared Special

K073626 - BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM

K073626 is an FDA 510(k) clearance for BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM, 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 41-day FDA review.

K073626 · Bio-Logic Systems Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
41d
Days
Class 2
Risk

K073626 is an FDA 510(k) clearance for the BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mundelein, US). The FDA issued a Cleared decision on February 5, 2008 after a review of 41 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.

FDA 510(k) Submission Details - K073626

510(k) Number K073626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date February 05, 2008
Days to Decision 41 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
108d faster than avg
Panel avg: 149d · This submission: 41d
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 61
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K073626 · BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
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