FDA 510(k)

Purgo

K-Number: K213753 · 2022-06-01

Decision Date2022-06-01

Product CodeFRA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Purgo is the device name listed in this FDA 510(k) record. The listed applicant is Aeroclean Technologies, LLC. It received FDA 510(k) clearance on 2022-06-01 under 510(k) 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. The listed applicant is Aeroclean Technologies, LLC. The 510(k) number is K213753.

When did Purgo receive FDA 510(k) clearance?

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

Who is the listed applicant for Purgo?

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

What is the FDA product code for Purgo?

The FDA product code for Purgo is FRA.

Other records listing Aeroclean Technologies, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223328Purgo

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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.