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) Official FDA 510(k) Summary (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.

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
59d faster than avg
Panel avg: 149d · 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 53
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K963669.
SANDMAN SD20 AMPLIFIER
K040113 · Eb Neuro S.P.A. · Feb 2004
MIZAR, BASIS BE, SANDMAN DIGITAL
K003154 · Eb Neuro S.P.A. · Jan 2001
SENSOR AMPLIFIER
K972515 · Pro-Tech Services, Inc. · Oct 1997
MMC AMPLIFIER
K943673 · Melville Software , Ltd. · Oct 1994
OPTI-AMP
K914876 · Intelligent Hearing Systems · Jan 1992
AM-PAK
K912436 · Cns, Inc. · Oct 1991
K963669 · GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
Download PDF FDA Summary Astro-Med, Inc.