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510(k) Data Aggregation
K Number
K201220Device Name
Aerus Medical Guardian,model F170A
Manufacturer
Aerus Medical LLC
Date Cleared
2020-06-17
(42 days)
Product Code
FRA
Regulation Number
880.6500Why did this record match?
Applicant Name (Manufacturer) :
Aerus Medical LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aerus Medical Guardian, model F170A is a device intended for medical purposes that is used for the reduction of staphylococcus epidermidis and erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillus niger fungal spores and bacillus globigii bacterial spores from the air in a temperature-controlled professional healthcare environment of 70~71°F, 40~45% RH.
Device Description
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