Cleared Traditional

K841683 - Q.P. PREAMPLIFIER SYS

K841683 is the FDA 510(k) clearance for Q.P. PREAMPLIFIER SYS by Bio-Scan, Inc.. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K841683 · Bio-Scan, Inc. · Neurology device
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Jun 1984
Decision
45d
Days
Class 2
Risk

K841683 is an FDA 510(k) clearance for the Q.P. PREAMPLIFIER SYS. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Bio-Scan, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 7, 1984 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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-Scan, Inc. devices

Submission Details

510(k) Number K841683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date June 07, 1984
Days to Decision 45 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 148d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 - GWQ Full-montage Standard Electroencephalograph

All 89
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K841683.
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