Cleared Traditional

K900063 - MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)

K900063 is an FDA 510(k) clearance for MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA), manufactured by Bio-Feedback Systems, Inc.. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K900063 · Bio-Feedback Systems, Inc. · Neurology device
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Feb 1990
Decision
44d
Days
Class 2
Risk

K900063 is an FDA 510(k) clearance for the MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA). Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Bio-Feedback Systems, Inc. (Boulder, US). The FDA issued a Cleared decision on February 16, 1990 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio-Feedback Systems, Inc. devices

FDA 510(k) Submission Details - K900063

510(k) Number K900063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1990
Decision Date February 16, 1990
Days to Decision 44 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 148d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWL Device Classification - Class 2, Special Controls

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 35
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K900063.
NIC36 AMPLIFIER
K041198 · Eb Neuro S.P.A. · Jun 2004
SENSOR AMPLIFIER
K972515 · Pro-Tech Services, Inc. · Oct 1997
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
K963669 · Astro-Med, Inc. · Dec 1996
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K881177 · Nihon Kohden America, Inc. · Sep 1988
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
K870794 · Nihon Kohden America, Inc. · Sep 1987
NICOLET AMP 6R11 SYSTEM
K871678 · Nicolet Biomedical Instruments · Jul 1987