MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV

• K Number: K972064
• Device Name: MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
• Manufacturer: BIOLOGICAL CONTROLS, INC.
• Date Cleared: 1997-12-01 ( 181 days)
• Product Code: FRA
• Regulation Number: 880.6500
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a previously marketed device. It acknowledges the device's indications for use but does not detail any performance metrics, study designs, sample sizes, expert qualifications, or ground truth methodologies that would be necessary to answer your request.

The text is a regulatory approval document and not a scientific study report.

Regulation Number and Section

§ 880.6500 Medical ultraviolet air purifier.

(a)
Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.(b)
Classification. Class II (performance standards).