Purgo

Purifier, Air, Ultraviolet, Medical

AeroClean Technologies, Inc.

The following data is part of a premarket notification filed by Aeroclean Technologies, Inc. with the FDA for Purgo.

Pre-market Notification Details

• Device ID: K223328
• 510k Number: K223328
• Device Name: Purgo
• Classification: Purifier, Air, Ultraviolet, Medical
• Applicant: AeroClean Technologies, Inc. 10455 Riverside Drive, Ste. 100 Palm Beach Gardens, FL 33410
• Contact: Richard Foster
• Correspondent: Rita King; MethodSense, Inc. 1 Copley Pkwy, Ste. 410 Morrisville, NC 27560
• Product Code: FRA
• CFR Regulation Number: 880.6500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-10-31
• Decision Date: 2022-11-30