Cleared Traditional

K973355 - ADVANTAGE 3000

K973355 is an FDA 510(k) clearance for ADVANTAGE 3000, manufactured by Advantage Medical Division of Cme Telemetrix. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K973355 · Advantage Medical Division of Cme Telemetrix · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
88d
Days
Class 2
Risk

K973355 is an FDA 510(k) clearance for the ADVANTAGE 3000. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Advantage Medical Division of Cme Telemetrix (London, CA). The FDA issued a Cleared decision on December 5, 1997 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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.

FDA 510(k) Submission Details - K973355

510(k) Number K973355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date December 05, 1997
Days to Decision 88 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
61d faster than avg
Panel avg: 149d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 60
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K973355.
TOENNIES NEUROSCREEN SYSTEM
K972419 · Erich Jaeger, Inc. · Apr 1998
MLS ELECTROMYOGRAPHIC PREAMPLIFIER
K974385 · Motion Lab Systems, Inc. · Feb 1998
ADVANTAGE EMG SYSTEM, MODEL #A100
K974010 · Advantage Medical Division of Cme Telemetrix · Jan 1998
EXCEL EMG
K941144 · Excel Tech. , Ltd. · Nov 1995
COMPUTER DYNO/GONIO/MYO GRAPHY
K942965 · Infotronic Medical Engineering · Oct 1995
B & L ELECTRODE
K952655 · B & L Engineering · Sep 1995
K973355 · ADVANTAGE 3000
Download PDF FDA Summary Advantage Medical Div…