The following data is part of a premarket notification filed by Eurosets S.r.l. with the FDA for Advanced Membrane Gas Exchange (amg), Amg Oxygenaling Module, Amg Venous Cardiotomy Resevoir 4500 Model Eu5011, Eu5012.
| Device ID | K102109 |
| 510k Number | K102109 |
| Device Name: | ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012 |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | EUROSETS S.R.L. VIA G. PUCCINI, 1 Medolla, Modena, IT I-43036 |
| Contact | Mario Genmari |
| Correspondent | Mario Genmari EUROSETS S.R.L. VIA G. PUCCINI, 1 Medolla, Modena, IT I-43036 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-28 |
| Decision Date | 2011-02-15 |
| Summary: | summary |