K Number
K010616Device Name
DEFENDER ROOM AIR CLEANER, MODEL RAC-4000AManufacturer
Date Cleared
2001-03-28
(27 days)
Product Code
Regulation Number
880.5045Type
SpecialPanel
HOReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 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).