K221702 is an FDA 510(k) clearance for the CompuFlo Epidural Computer Controlled Anesthesia System. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Milestone Scientific, Inc. (Roseland, US). The FDA issued a Cleared decision on February 25, 2023, 257 days after receiving the submission on June 13, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K221702 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2022 |
| Decision Date | February 25, 2023 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |