Cleared Traditional

K822700 - DEL MAR MODEL 5500 EEG SCANNER

K822700 is the FDA 510(k) clearance for DEL MAR MODEL 5500 EEG SCANNER by Del Mar Avionics. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K822700 · Del Mar Avionics · Neurology device
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Oct 1982
Decision
27d
Days
Class 2
Risk

K822700 is an FDA 510(k) clearance for the DEL MAR MODEL 5500 EEG 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 October 4, 1982 after a review of 27 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 Del Mar Avionics devices

Submission Details

510(k) Number K822700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1982
Decision Date October 04, 1982
Days to Decision 27 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
121d faster than avg
Panel avg: 148d · This submission: 27d
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 88
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K822700.
EEG 42/2P ELECTRO ENCEPHALOGRAPH
K831324 · Nihon Kohden America, Inc. · May 1983
MEDILOG 9000 SYSTEM
K830295 · Oxford Medilog, Inc. · Mar 1983
ELECTROENCEPHALOGRAPH
K823140 · Nihon Kohden America, Inc. · Dec 1982
OTE BIOMEDICAL #1296 - 16 CHAN. RECORD
K820779 · Del Mar Avionics · Apr 1982
OTE BIOMEDICA NEUROGRAPH 14
K820603 · Del Mar Avionics · Mar 1982
OTE BIOMEDICA NEUROGRAPH 9
K820604 · Del Mar Avionics · Mar 1982