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type 9290 interface respirator
S & W Medico Teknik
Summary: The Type 9290 Interface Respirator is a medical device used for respiratory support, primarily in surgical and critical care settings. It is used by healthcare professionals to assist patients with breathing.
FDA Clearance Information
Pathway
510K
Number
K896735 ↗
Decision Date
February 28, 1990
Product Code
CBK
Device Class
Class 2
Evidence
0 studies
The Type 9290 Interface Respirator was cleared through the FDA 510(k) pathway on February 28, 1990. Manufactured by S & W Medico Teknik, it is classified as a Class 2 device under product code CBK.
What It Is
The Type 9290 Interface Respirator is a medical device designed to provide respiratory support to patients who are unable to breathe adequately on their own. It functions by delivering controlled airflow to maintain adequate oxygenation and ventilation. This device is crucial in settings where patients require mechanical assistance to breathe, such as during surgery or in intensive care units.
Clinical Applications
This respirator is commonly used in operating rooms and intensive care units, where patients may be under anesthesia or suffering from conditions that impair their respiratory function. It is utilized by anesthesiologists, critical care specialists, and respiratory therapists to ensure that patients maintain adequate ventilation and oxygenation. The device is suitable for a wide range of patient populations, including those with compromised lung function or undergoing major surgical procedures.
Indications for Use
The FDA indications suggest that the Type 9290 Interface Respirator is intended for patients who require mechanical ventilation due to respiratory failure or during surgical procedures. It is suitable for individuals who cannot maintain adequate breathing on their own.
Practical Considerations
The Type 9290 Interface Respirator typically comes in various sizes to accommodate different patient needs and is compatible with standard hospital ventilation systems. Clinicians should be trained in its use to ensure proper setup and monitoring during patient care.
Frequently Asked Questions
What is the Type 9290 Interface Respirator used for?
It is used to provide mechanical respiratory support to patients who cannot breathe adequately on their own.
What specialties typically use this device?
Anesthesiologists, critical care specialists, and respiratory therapists commonly use this device in surgical and intensive care settings.
What are the FDA-cleared indications?
It is indicated for patients requiring mechanical ventilation due to respiratory failure or during surgical procedures.
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.