Cleared Traditional

K963662 - GALILEO EVOKED POTENTIALRE

K963662 is an FDA 510(k) clearance for GALILEO EVOKED POTENTIALRE, manufactured by Biosound, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K963662 · Biosound, Inc. · Neurology device
Download Printable Device Report (PDF)
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Feb 1997
Decision
166d
Days
Class 2
Risk

K963662 is an FDA 510(k) clearance for the GALILEO EVOKED POTENTIALRE. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 26, 1997 after a review of 166 days - an extended review 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: 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 Biosound, Inc. devices

FDA 510(k) Submission Details - K963662

510(k) Number K963662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1996
Decision Date February 26, 1997
Days to Decision 166 days
Submission Type Traditional
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
18d slower than avg
Panel avg: 148d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

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 54
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K963662.
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K991899 · Nihon Kohden America, Inc. · Sep 1999
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
K992313 · Excel Tech. , Ltd. · Aug 1999
FOUR-CHANNEL PREAMPLIFIER
K962455 · Cadwell Laboratories, Inc. · Jan 1997
TWO-CHANNEL PREAMPLIFIER
K962457 · Cadwell Laboratories, Inc. · Jan 1997
CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER
K962458 · Cadwell Laboratories, Inc. · Jan 1997