MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP

• K Number: K974682
• Device Name: MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
• Manufacturer: BIOLOGICAL CONTROLS, INC.
• Date Cleared: 1998-01-23 ( 39 days)
• Product Code: FRF
• Regulation Number: 880.5045
• 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

The provided document is a 510(k) clearance letter from the FDA for several air purifier devices (Microcon 800M, 400M, Ex, ExC and Wall-Map Air Purifier). It states that the devices are substantially equivalent to pre-amendment devices for the indication of filtering airborne particles from air for medical purposes.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information. The letter only grants market clearance based on substantial equivalence, implying that the manufacturer would have submitted data to demonstrate this equivalence in their 510(k) submission, but that data is not part of this letter.

Regulation Number and Section

§ 880.5045 Medical recirculating air cleaner.

(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).