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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K201220

Aerus Medical Guardian,model F170A · Aerus Medical, LLC · decided 2020-06-17 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ActivePure Medical GuardianF170AACTIVEPURE MEDICAL LLCFRA00860006810108
Medical GuardianF170AAerus LLCFRA00860006514808