The following data is part of a premarket notification filed by Aea Srl with the FDA for Apoteca Dug Compounding Dosing Device,apoteca I.v. Transfer Set.
| Device ID | K132011 |
| 510k Number | K132011 |
| Device Name: | APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET |
| Classification | Syringe, Piston |
| Applicant | AEA SRL Via Fiume 16 Angeli Di Rosora, IT 60030 |
| Contact | Michele Mengoni |
| Correspondent | Michele Mengoni AEA SRL Via Fiume 16 Angeli Di Rosora, IT 60030 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2014-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060304050137 | K132011 | 000 |
| 05060304050977 | K132011 | 000 |
| 05060304050984 | K132011 | 000 |
| 05060304050991 | K132011 | 000 |
| 05060304051004 | K132011 | 000 |
| 05060304051011 | K132011 | 000 |
| 05060304050007 | K132011 | 000 |
| 05060304050014 | K132011 | 000 |
| 05060304050021 | K132011 | 000 |
| 05060304050038 | K132011 | 000 |
| 05060304050045 | K132011 | 000 |
| 05060304050106 | K132011 | 000 |
| 05060304050113 | K132011 | 000 |
| 05060304050120 | K132011 | 000 |
| 05060304050960 | K132011 | 000 |