Cleared Traditional

K964280 - DG NERVUS

K964280 is an FDA 510(k) clearance for DG NERVUS, manufactured by Medelec , Ltd.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K964280 · Medelec , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
91d
Days
Class 2
Risk

K964280 is an FDA 510(k) clearance for the DG NERVUS. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Medelec , Ltd. (Old Woking, Surrey, DE). The FDA issued a Cleared decision on January 27, 1997 after a review of 91 days - within the typical 510(k) review window.

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.

View all Medelec , Ltd. devices

FDA 510(k) Submission Details - K964280

510(k) Number K964280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1996
Decision Date January 27, 1997
Days to Decision 91 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 148d · This submission: 91d
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 131
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K964280.
SATELLITE
K971331 · Nicolet Biomedical, Inc. · Jun 1997
MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM
K970942 · Physiometrix, Inc. · Jun 1997
GALILEO HALLEY
K970703 · Biosound Esaote, Inc. · May 1997
MEDILOG MR95
K961642 · Oxford Instruments, Plc. · Jan 1997
EQUINOX DIGITAL EEG SYSTEM
K962447 · Physiometrix, Inc. · Dec 1996
MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM
K962157 · Physiometrix, Inc. · Nov 1996