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K Number
K960966
Device Name
HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588
Manufacturer
SUNBEAM-OSTER HOUSEHOLD PRODUCTS
Date Cleared
1997-01-10

(305 days)

Product Code
FRF
Regulation Number
880.5045
Type
Traditional
Panel
HO
Reference & 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).