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sensmart model 8006ca reusable regional oximetry sensor sensmart model 8006pi disposable patient interface
Nonin Medical
Summary: The Sensmart Model 8006CA is a reusable regional oximetry sensor, and the Model 8006PI is a disposable patient interface, both used for monitoring tissue oxygenation. They are primarily used by clinicians in settings requiring precise oxygenation monitoring.
FDA Clearance Information
Pathway
510K
Number
K190560 ↗
Decision Date
May 2, 2019
Product Code
MUD
Device Class
Class 2
Evidence
0 studies
The Sensmart Model 8006CA and 8006PI were cleared through the FDA 510k pathway on May 2, 2019. Manufactured by Nonin Medical, these devices are classified as Class 2 under product code MUD.
What It Is
The Sensmart Model 8006CA is a reusable sensor designed to measure regional oxygen saturation (rSO2) in tissues, providing clinicians with critical data on tissue oxygenation. The Model 8006PI is a disposable interface that ensures hygienic application of the sensor. These devices utilize near-infrared spectroscopy to non-invasively assess oxygen levels, which is crucial in various medical settings.
Clinical Applications
These devices are commonly used in surgical and critical care settings where monitoring of regional tissue oxygenation is crucial, such as during ablation procedures or in patients with compromised blood flow. They are particularly useful in specialties like anesthesiology, cardiology, and neurology. The devices are suitable for use in both adult and pediatric populations, providing valuable data to guide clinical decision-making.
Indications for Use
The FDA-cleared indications suggest that these devices are intended for monitoring tissue oxygenation in patients undergoing procedures that may affect blood flow or oxygen delivery. They are particularly useful in assessing the effectiveness of interventions aimed at improving tissue perfusion.
Practical Considerations
The Sensmart Model 8006CA sensor is reusable, making it cost-effective for repeated use, while the 8006PI interface is disposable, ensuring patient safety and hygiene. Compatibility with existing monitoring systems should be verified, and clinicians should be trained in proper placement and interpretation of the readings for optimal results.
Frequently Asked Questions
What is Sensmart Model 8006CA/8006PI used for?
It is used for monitoring regional tissue oxygenation in clinical settings, providing data on tissue perfusion and oxygen delivery.
What specialties typically use this device?
Specialties such as anesthesiology, cardiology, and neurology commonly use these devices, especially in surgical and critical care settings.
What are the FDA-cleared indications?
The device is indicated for monitoring tissue oxygenation in patients undergoing procedures that may impact blood flow or oxygen delivery.
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.