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FDA 510(k), K201220, Aerus Medical Guardian,model F170A
FDA 510(k), K201220, Aerus Medical Guardian,model F170A
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510(K) Number: K201220
Device Name: Aerus Medical Guardian,model F170A
Manufacturer: Aerus Medical LLC
Device Classification Name: Purifier, Air, Ultraviolet, Medical
Regulation Number: 880.6500
Classification Product Code: FRA
Date Received: 05/06/2020
Decision Date: 06/17/2020
Regulation Medical Specialty: General Hospital
Device Name: Aerus Medical Guardian,model F170A
Manufacturer: Aerus Medical LLC
Device Classification Name: Purifier, Air, Ultraviolet, Medical
Regulation Number: 880.6500
Classification Product Code: FRA
Date Received: 05/06/2020
Decision Date: 06/17/2020
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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