Aerus Medical Guardian,model F170A— 510(k) K201220

Name: FDA 510(k) clearance K201220
Creator: U.S. Food and Drug Administration
Published: 2020-06-17

Substantially Equivalent

Aerus Medical, LLC

FDA 510(k) clearance K201220 for Aerus Medical Guardian,model F170A, Substantially Equivalent on 2020-06-17. Applicant: Aerus Medical, LLC. Device class: 2.

Clearance details

Applicant: Aerus Medical, LLC
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2020-05-06
Decision date: 2020-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.