K242102 is an FDA 510(k) clearance for the CerroZone Mini. This device is classified as a Cleaner, Air, Medical Recirculating (Class II - Special Controls, product code FRF).
Submitted by Cerrozone, LLC (Maryland Heights, US). The FDA issued a Cleared decision on November 19, 2024, 124 days after receiving the submission on July 18, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5045.
| 510(k) Number | K242102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2024 |
| Decision Date | November 19, 2024 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRF - Cleaner, Air, Medical Recirculating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5045 |