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510(k) K213753

Purgo by Aeroclean Technologies, LLC — Product Code FRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2022
Date Received
November 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Purifier, Air, Ultraviolet, Medical
Device Class
Class II
Regulation Number
880.6500
Review Panel
HO
Submission Type

Other clearances by Aeroclean Technologies, LLC

  • K223328 — Purgo (November 30, 2022)

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