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model 1001 hydrodot tm neuromonitoring system with e net tm eeg interface cable
Physiometrix
Summary: The Model 1001 Hydrodot TM Neuromonitoring System is a device used for EEG monitoring, primarily in neurosurgical settings. It is utilized by neurologists and neurosurgeons to monitor brain activity during procedures.
FDA Clearance Information
Pathway
510K
Number
K946318 ↗
Decision Date
April 24, 1995
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on April 24, 1995, by Physiometrix. It is classified as a Class 2 device under product code GXY.
What It Is
The Model 1001 Hydrodot TM Neuromonitoring System is an EEG monitoring device designed to provide real-time brain activity data. It uses the E Net TM EEG interface cable to connect electrodes to the patient's scalp, allowing clinicians to monitor electrical activity in the brain. This system is particularly useful in surgical settings where continuous EEG monitoring is necessary.
Clinical Applications
This device is commonly used in neurosurgical procedures to monitor brain activity and ensure patient safety. It is particularly valuable in surgeries involving brain tumors or other neurological conditions where brain function needs to be closely observed. Neurologists and neurosurgeons in hospital operating rooms are the primary users, often working with anesthesiologists to interpret the data.
Indications for Use
The FDA indications suggest this device is intended for use in monitoring brain activity during surgical procedures. It is suitable for patients undergoing neurosurgery, particularly those with brain tumors or other conditions requiring detailed brain monitoring.
Practical Considerations
The device is compatible with standard EEG electrode setups and requires proper placement for accurate readings. Clinicians should ensure the interface cable is securely connected and check for any signal interference during use.
Frequently Asked Questions
What is the Model 1001 Hydrodot TM Neuromonitoring System used for?
It is used for real-time EEG monitoring of brain activity during surgical procedures, particularly in neurosurgery.
What specialties typically use this device?
Neurologists and neurosurgeons, often in collaboration with anesthesiologists, use this device in hospital operating rooms.
What are the FDA-cleared indications?
The device is indicated for monitoring brain activity during surgical procedures, especially in patients undergoing neurosurgery for conditions like brain tumors.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.