Model 1001, Hydrodot Neuromonitoring System with E Net EEG Interface Cable

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Model 1001, Hydrodot(Tm) Neuromonitoring System with E Net(Tm) EEG Interface Cable

510(k) Number

K946318 ↗

FDA Product Code

GXY

Device Class

Class II

Regulation

21 CFR Part 882.1320

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Sedline Sedation Monitor with Frontal Psi and Sedtrace EEG Electrose Set

  Class II

  FDA 510(k) K051874 Active Cleared 2 Sep 2005

• Model 1320, Neurolink II Neuromonitoring System

  Class II

  FDA 510(k) K970942 Active Cleared 2 Jun 1997

• Model 4310 PSARRAY2 EEG Electrode

  Class II

  FDA 510(k) K020670 Active Cleared 8 Oct 2002

• Model 1210, Medium E-Net

  Class II

  FDA 510(k) K960873 Active Cleared 26 Apr 1996

• Equinox Digital EEG System

  Class II

  FDA 510(k) K962447 Active Cleared 12 Dec 1996

• Model 1700, Hydro Prep

  Class II

  FDA 510(k) K970694 Active Cleared 14 May 1997

See all devices from Physiometrix, Inc. →

• What is the Model 1001 Hydrodot Neuromonitoring System used for?

  The Model 1001 Hydrodot Neuromonitoring System is designed to provide real-time brain activity data by monitoring electrical activity in the brain through scalp electrodes connected via the E Net EEG interface cable, intended for use in clinical neurology settings.

• How does the E Net EEG interface cable function in the Model 1001 system?

  The E Net EEG interface cable connects electrodes to the patient's scalp, enabling the transmission of electrical brain activity signals to the monitoring system for real-time data acquisition and clinical assessment.

• Is the Model 1001 Hydrodot Neuromonitoring System a reusable or single-use device?

  The device data does not specify whether the Model 1001 Hydrodot Neuromonitoring System or its components are single-use or reusable; therefore, reuse status cannot be determined from the provided information.

• What regulatory pathway was used for the Model 1001 Hydrodot Neuromonitoring System?

  The Model 1001 Hydrodot Neuromonitoring System received FDA 510(k) clearance through the traditional pathway, demonstrating substantial equivalence to a predicate device under product code GXY, with clearance granted on April 24, 1995, under K number K946318.

• Who manufactures the Model 1001 Hydrodot Neuromonitoring System and where is it located?

  The Model 1001 Hydrodot Neuromonitoring System is manufactured by Physiometrix, Inc., located at Five Billerica Park, 101 Billerica Ave., North Billerica, MA 01862, United States.