Cleared Traditional

K963669 - GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM

K963669 is an FDA 510(k) clearance for GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM, manufactured by Astro-Med, Inc.. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K963669 · Astro-Med, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
90d
Days
Class 2
Risk

K963669 is an FDA 510(k) clearance for the GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Astro-Med, Inc. (West Warwick, US). The FDA issued a Cleared decision on December 12, 1996 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 882.1835 - 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 Astro-Med, Inc. devices

FDA 510(k) Submission Details - K963669

510(k) Number K963669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1996
Decision Date December 12, 1996
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.

GWL Device Classification - Class 2, Special Controls

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 28
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K963669.
SINGLE AMPLIFIER FOR BOTOX
K051852 · Allergan, Inc. · Sep 2005
NIC36 AMPLIFIER
K041198 · Eb Neuro S.P.A. · Jun 2004
SENSOR AMPLIFIER
K972515 · Pro-Tech Services, Inc. · Oct 1997
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K881177 · Nihon Kohden America, Inc. · Sep 1988
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
K870794 · Nihon Kohden America, Inc. · Sep 1987
NICOLET AMP 6R11 SYSTEM
K871678 · Nicolet Biomedical Instruments · Jul 1987