Cleared Traditional

K980866 - MEDI-DX 7000 CPT WITH AMREX ELECTRODES

K980866 is an FDA 510(k) clearance for MEDI-DX 7000 CPT WITH AMREX ELECTRODES, manufactured by Neuro-Diagnostic Assoc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980866 · Neuro-Diagnostic Assoc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
90d
Days
Class 2
Risk

K980866 is an FDA 510(k) clearance for the MEDI-DX 7000 CPT WITH AMREX ELECTRODES. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Neuro-Diagnostic Assoc. (Laguna Beach, US). The FDA issued a Cleared decision on May 20, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Neuro-Diagnostic Assoc. devices

FDA 510(k) Submission Details - K980866

510(k) Number K980866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1998
Decision Date May 20, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 75
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K980866.
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES
K991899 · Nihon Kohden America, Inc. · Sep 1999
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
K992313 · Excel Tech. , Ltd. · Aug 1999
SYNERGY LT
K981405 · Oxford Instruments, Plc. · Jul 1998
AMPLAID MK12
K971740 · Amplifon S.P.A. · Mar 1998
AMPLAID MK22
K972959 · Amplifon S.P.A. · Feb 1998
EPOCH 2000 NEUROLOGICAL WORKSTATION
K971819 · Axon Systems, Inc. · Nov 1997