K161883 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. (Livingston, US). The FDA issued a Cleared decision on June 9, 2017, 333 days after receiving the submission on July 11, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K161883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2016 |
| Decision Date | June 09, 2017 |
| Days to Decision | 333 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |