K230083 is an FDA 510(k) clearance for the SAFIRA. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Medovate Limited (Girton, GB). The FDA issued a Cleared decision on October 31, 2023, 293 days after receiving the submission on January 11, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K230083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2023 |
| Decision Date | October 31, 2023 |
| Days to Decision | 293 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN - Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |