K963669 · Astro-Med, Inc. · GWL · Dec 12, 1996 · Neurology
Device Facts
Record ID
K963669
Device Name
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
Applicant
Astro-Med, Inc.
Product Code
GWL · Neurology
Decision Date
Dec 12, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 882.1835
Device Class
Class 2
Device Story
Neurodata Amplifier System; processes physiological signals. Device houses up to 32 amplifier circuits in single enclosure; replaces manual switches with solid-state switches controlled via RS-232 serial port. Used in clinical/diagnostic settings for neurological signal amplification. Operates via capacity-coupled patient circuit; safety-extra-low-voltage (12VDC) operation. Isolates patient-applied circuits from earth ground. Provides signal amplification for healthcare provider review; facilitates neurological diagnostic assessment.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Physiological signal amplifier; 32-channel capacity; solid-state switching; RS-232 serial interface; capacity-coupled patient circuit; 12VDC operation; patient-to-earth isolation.
Regulatory Classification
Identification
A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).
Predicate Devices
Grass Model P511
Melville Diagnostics MMC Series
Submission Summary (Full Text)
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K96 3669
EXHIBIT A DEC 12 1996
Grass-Instrument Division
Astro-Med, Inc.
Astro-Med Industrial Park
West Warwick, Rhode Island 02893 USA
Phone: (401) 828-4000
Fax: (401) 822-2430
Contact Person: Steve Johnson
September 16, 1996
510(k) Summary of Safety and Effectiveness
Grass ® Model 15
1. Identification of the Device
Classification Name: Amplifier, Physiological Signal, 84GWL, Reg. # 882.1835
Neurological Diagnostic Devices
Common/Usual Name: Neurodata Amplifier System
Proprietary-Trade Name: Grass ® Model 15 Neurodata Amplifier System
2. Equivalent legally marketed devices
This product is similar in design and function to the Grass ® Model P511 and Melville Diagnostics MMC Series amplifier systems.
The intended use and essential design, performance, and safety characteristics of the Model 15 are the same as the Grass Model P511 amplifier, a single-channel amplifier with manual control of all settings. The Grass P511 has been in production since 1968 and is still in current production and listed with the FDA. The Model 15 combines up to 32 of the P511 amplifier circuits (in banks of 4) in a single enclosure and replaces the P511 manual switches with solid-state switches that are controlled via a standard RS-232 serial port. The Model 15 relies on the essential safety features of the P511 amplifier - capacity-coupled patient circuit and safety-extra-low-voltage operation (12VDC) and improves on the safety of the P511 by isolating the patient applied circuits from the enclosure (earth).
