Purgo— 510(k) K213753

Substantially Equivalent

Aeroclean Technologies, LLC

FDA 510(k) clearance K213753 for Purgo, Substantially Equivalent on 2022-06-01. Applicant: Aeroclean Technologies, LLC. Device class: 2.

Clearance details

Applicant: Aeroclean Technologies, LLC
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2021-11-30
Decision date: 2022-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, 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.