Grass Model 15 Neurodata Amplifier System

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K963669 ↗

FDA Product Code

GWL

Device Class

Class II

Regulation

21 CFR Part 882.1835

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Dash IV

  Class I

  FDA 510(k) K912929 Active Cleared 13 Aug 1991

• Astro-Med Asc-951 Pressure Processor

  Class II

  FDA 510(k) K894295 Active Cleared 18 Jan 1990

• K3 System

  Class II

  FDA 510(k) K934644 Active Cleared 1 Nov 1994

• MT9000 Chart Recorder

  Class II

  FDA 510(k) K892067 Active Cleared 5 Jun 1989

• Asc-952 Physiological Amplifier

  Class II

  FDA 510(k) K894735 Active Cleared 18 Sep 1989

• Aura-Psg

  Class II

  FDA 510(k) K050425 Active Cleared 20 Oct 2005

See all devices from Astro-Med, Inc. →

• What is the Grass Model 15 Neurodata Amplifier System used for?

  The Grass Model 15 Neurodata Amplifier System is designed specifically for neurodiagnostic applications. It amplifies and processes electrical signals from the nervous system, enabling precise recording and analysis of neurophysiological data such as electroencephalograms (EEG), electromyograms (EMG), and evoked potentials. This functionality supports clinical assessments in neurology, helping diagnose and monitor neurological conditions by providing accurate and high-fidelity signal amplification and filtering.

• Is the Grass Model 15 Neurodata Amplifier System reusable or single-use?

  The Grass Model 15 Neurodata Amplifier System is supplied as a reusable medical device. Reusability is common for high-end diagnostic equipment like this, as it allows for proper maintenance, calibration, and sterilization procedures between uses. However, it is critical to follow manufacturer guidelines for cleaning, disinfection, and maintenance to ensure accurate performance and patient safety.

• What regulatory approval does the Grass Model 15 Neurodata Amplifier System hold?

  The Grass Model 15 Neurodata Amplifier System holds FDA 510(k) clearance under the classification of an Amplifier, Physiological Signal (Regulation 882.1835). This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device and meets the regulatory standards for use in clinical electrodiagnostic laboratories and hospital settings. The clearance number is K963669.

• What types of clinical settings is the Grass Model 15 Neurodata Amplifier System intended for?

  The Grass Model 15 Neurodata Amplifier System is intended for use in clinical electrodiagnostic laboratories and hospital settings. It is connected to electrodes placed on or within a patient’s body to amplify and process electrical signals for neurodiagnostic assessments. These settings require specialized equipment to ensure accurate and reliable neurophysiological data collection, making this amplifier suitable for environments where precise monitoring of neurological activity is essential.

• Are there any specific storage or maintenance requirements for the Grass Model 15 Neurodata Amplifier System?

  While the provided data does not specify detailed storage instructions, reusable medical devices like the Grass Model 15 Neurodata Amplifier System generally require proper storage conditions to protect them from physical damage, dust, and environmental contaminants. Maintenance includes regular calibration to ensure signal accuracy and adherence to manufacturer-recommended cleaning and disinfection protocols between uses. Always refer to the manufacturer’s instructions for specific guidelines to maintain optimal performance and compliance with regulatory standards.