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FDA 510(k)

Purgo

K-Number: K213753 · 2022-06-01

ApplicantAeroclean Technologies, LLC
Decision Date2022-06-01
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Purgo is a medical device manufactured by Aeroclean Technologies, LLC. It received FDA 510(k) clearance on 2022-06-01 under approval number K213753. 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 Purgo?

Purgo is a medical device that received FDA 510(k) clearance on 2022-06-01. It is manufactured by Aeroclean Technologies, LLC. The 510(k) number is K213753.

When was Purgo approved by the FDA?

Purgo received FDA 510(k) clearance on 2022-06-01, under approval number K213753.

What company makes Purgo?

Purgo is manufactured by Aeroclean Technologies, LLC.

What is the FDA product code for Purgo?

The FDA product code for Purgo is FRA.

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Official Source

View on FDA Database →

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

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