FDA 510(k)

Aerus Medical Guardian,model F170A

K-Number: K201220 · 2020-06-17

Decision Date2020-06-17

Product CodeFRA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Aerus Medical Guardian,model F170A is the device name listed in this FDA 510(k) record. The listed applicant is Aerus Medical, LLC. It received FDA 510(k) clearance on 2020-06-17 under 510(k) number K201220. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aerus Medical Guardian,model F170A?

Aerus Medical Guardian,model F170A is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Aerus Medical, LLC. The 510(k) number is K201220.

When did Aerus Medical Guardian,model F170A receive FDA 510(k) clearance?

Aerus Medical Guardian,model F170A received FDA 510(k) clearance on 2020-06-17, under 510(k) number K201220.

Who is the listed applicant for Aerus Medical Guardian,model F170A?

The FDA 510(k) record lists Aerus Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aerus Medical Guardian,model F170A?

The FDA product code for Aerus Medical Guardian,model F170A is FRA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.