Aerus Medical Guardian,model F170A

Purifier, Air, Ultraviolet, Medical

Aerus Medical LLC

The following data is part of a premarket notification filed by Aerus Medical Llc with the FDA for Aerus Medical Guardian,model F170a.

Pre-market Notification Details

Device IDK201220
510k NumberK201220
Device Name:Aerus Medical Guardian,model F170A
ClassificationPurifier, Air, Ultraviolet, Medical
Applicant Aerus Medical LLC 14841 Dallas Parkway, Suite 500, The Aberdeen Bldg. Dallas,  TX  75254
ContactAndrew Eide
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeFRA  
CFR Regulation Number880.6500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-05-06
Decision Date2020-06-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860006514808 K201220 000
00860006810108 K201220 000

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