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freedom oximeter eeg digital interface
Pro-Tech
Summary: The Freedom Oximeter EEG Digital Interface by Pro-Tech is a medical device used to monitor oxygen saturation and EEG signals. It is primarily used by neurologists and anesthesiologists in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K924752 ↗
Decision Date
September 10, 1993
Product Code
DQA
Device Class
Class 2
Evidence
0 studies
The Freedom Oximeter EEG Digital Interface was cleared by the FDA via the 510k pathway on September 10, 1993. It is manufactured by Pro-Tech and classified as a Class 2 device under product code DQA.
What It Is
The Freedom Oximeter EEG Digital Interface is a medical device designed to measure and display oxygen saturation levels and EEG signals. It integrates oximetry and EEG monitoring, providing real-time data that is crucial in assessing patient status during various medical procedures. This device is particularly useful in settings where continuous monitoring of both oxygen levels and brain activity is required.
Clinical Applications
This device is commonly used in operating rooms, intensive care units, and during sleep studies. It is particularly valuable in neurology and anesthesiology, where monitoring both oxygen saturation and EEG is critical. Patients undergoing surgery, those with neurological disorders, or individuals being evaluated for sleep apnea may benefit from this device's capabilities.
Indications for Use
The FDA indications suggest that this device is intended for patients who require monitoring of oxygen saturation and EEG activity. This includes individuals undergoing surgical procedures, those with respiratory or neurological conditions, and patients in critical care settings.
Practical Considerations
The device is typically compatible with standard EEG and oximeter sensors. Clinicians should ensure proper sensor placement for accurate readings. It is important to verify compatibility with existing monitoring systems in the clinical setting.
Frequently Asked Questions
What is the Freedom Oximeter EEG Digital Interface used for?
It is used to monitor oxygen saturation and EEG signals in patients, providing critical data during medical procedures and in critical care settings.
What specialties typically use this device?
Neurologists, anesthesiologists, and critical care specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for monitoring oxygen saturation and EEG activity in patients, particularly during surgeries and in critical care.
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.