510(k) K220298
K220298 is an FDA 510(k) premarket notification submitted by Cerrozone for the device "CerroZone Mobile". The FDA issued a decision of Substantially Equivalent on July 1, 2022. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045. Cerrozone has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2022
- Date Received
- February 2, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleaner, Air, Medical Recirculating
- Device Class
- Class II
- Regulation Number
- 880.5045
- Review Panel
- HO
- Submission Type