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K Number
K954448

Validate with FDA (Live)

Device Name
VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
Manufacturer
SCHIFF & CO.
Date Cleared
1996-10-28

(399 days)

Product Code
FRA
Regulation Number
880.6500
Type
Traditional
Panel
General Hospital
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).