đź“‹ FDA Reference
type 9293 interface pulseox
S & W Medico Teknik
Summary: The Type 9293 Interface Pulseox is a medical device used for monitoring oxygen saturation levels in patients. It is typically utilized by healthcare professionals in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K896738 ↗
Decision Date
August 14, 1990
Product Code
DQA
Device Class
Class 2
Evidence
0 studies
The Type 9293 Interface Pulseox, manufactured by S & W Medico Teknik, received FDA clearance via the 510k pathway on August 14, 1990. It is classified as a Class 2 device under product code DQA.
What It Is
The Type 9293 Interface Pulseox is a pulse oximeter designed to non-invasively measure the oxygen saturation of a patient's blood. It works by emitting light through a patient's fingertip and measuring the amount of light absorbed by oxygenated and deoxygenated hemoglobin. This device provides real-time monitoring, which is crucial in assessing respiratory function and guiding treatment decisions.
Clinical Applications
This pulse oximeter is commonly used in settings such as hospitals, clinics, and during surgical procedures to monitor patients' oxygen levels. It is particularly useful in specialties like anesthesiology, emergency medicine, and critical care. The device is suitable for a wide range of patient populations, including adults, pediatrics, and neonates, depending on the sensor compatibility.
Indications for Use
The FDA indications suggest that this device is intended for monitoring oxygen saturation in patients who require continuous or spot-checking of blood oxygen levels. It is particularly indicated for patients with respiratory or cardiac conditions where oxygen monitoring is critical.
Practical Considerations
The Type 9293 Interface Pulseox typically comes with various sensor sizes to accommodate different patient demographics. It is important to ensure compatibility with other monitoring systems and to follow proper placement techniques for accurate readings.
Frequently Asked Questions
What is the Type 9293 Interface Pulseox used for?
It is used for monitoring oxygen saturation levels in patients' blood, providing critical information about their respiratory status.
What specialties typically use this device?
Specialties such as anesthesiology, emergency medicine, and critical care commonly use this device.
What are the FDA-cleared indications?
It is indicated for monitoring blood oxygen levels in patients, particularly those with respiratory or cardiac conditions.
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.