510(k) K203189
K203189 is an FDA 510(k) premarket notification submitted by Aerobiotix, Inc. for the device "AEROCURE-MD". The FDA issued a decision of Substantially Equivalent on January 21, 2021. The device falls under product code FRA (Purifier, Air, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2021
- Date Received
- October 27, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Purifier, Air, Ultraviolet, Medical
- Device Class
- Class II
- Regulation Number
- 880.6500
- Review Panel
- HO
- Submission Type