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 |