510(k) K223328
K223328 is an FDA 510(k) premarket notification submitted by Aeroclean Technologies, Inc. for the device "Purgo". The FDA issued a decision of Substantially Equivalent on November 30, 2022. The device falls under product code FRA (Purifier, Air, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6500. Aeroclean Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2022
- Date Received
- October 31, 2022
- Clearance Type
- Special
- 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