K132011 is an FDA 510(k) clearance for the APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Aea Srl (Angeli Di Rosora, IT). The FDA issued a Cleared decision on March 21, 2014, 263 days after receiving the submission on July 1, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K132011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2013 |
| Decision Date | March 21, 2014 |
| Days to Decision | 263 days |
| Submission Type | Abbreviated |
| 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 |