Cleared Traditional

K963669 - GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
(FDA 510(k) Clearance)

K963669 · Astro-Med, Inc. · Neurology device

Dec 1996

Decision

90d

Days

Class 2

Risk

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

Submitted by Astro-Med, Inc. (West Warwick, US). The FDA issued a Cleared decision on December 12, 1996, 90 days after receiving the submission on September 13, 1996.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1835.

Submission Details

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