DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A by HMI INDUSTRIES, INC. | FDA 510(k) Summary

FDA 510(k) Search

K Number

Device Name

DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A

Manufacturer

HMI INDUSTRIES, INC.

Date Cleared

2000-11-17

(80 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Summary

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).