Cleared Traditional

K841653 - DEL MAR AVIONICS 5509 NEURO-SCANNER

K841653 is an FDA 510(k) clearance for DEL MAR AVIONICS 5509 NEURO-SCANNER, manufactured by Del Mar Avionics. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K841653 · Del Mar Avionics · Neurology device
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Dec 1984
Decision
224d
Days
Class 2
Risk

K841653 is an FDA 510(k) clearance for the DEL MAR AVIONICS 5509 NEURO-SCANNER. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Del Mar Avionics (Mchenry, US). The FDA issued a Cleared decision on December 3, 1984 after a review of 224 days - an extended review 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: 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.

FDA 510(k) Submission Details - K841653

510(k) Number K841653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date December 03, 1984
Days to Decision 224 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 149d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

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 188
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K841653.
TECA MONTAGE II
K851232 · Teca, Inc. · Jun 1985
ELECTROENCEPHALOGRAPH EEG
K850259 · Nicolet Biomedical Instruments · Apr 1985
CEREGROTRAC
K842784 · Advanced Instruments, Inc. · Jan 1985
EEG-4300 W/OPTINAL ACCESS. EEG 4314 &
K842714 · Nihon Kohden America, Inc. · Sep 1984
Q.P. PREAMPLIFIER SYS
K841683 · Bio-Scan, Inc. · Jun 1984
BIO/SCAN BIOLOG CASSETTE RECORDER
K841684 · Bio-Scan, Inc. · Jun 1984
K841653 · DEL MAR AVIONICS 5509 NEURO-SCANNER
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