The following data is part of a premarket notification filed by Eurosets S.r.l. with the FDA for Advanced Membrance Gas Exchange Pmp Sterile (a.m.g Pmp Sterile).
| Device ID | K141492 |
| 510k Number | K141492 |
| Device Name: | ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE) |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | EUROSETS S.R.L. VIA G. PUCCINI, 1 Medolla, Modena, IT I-43036 |
| Contact | Mario Gennari |
| Correspondent | Mario Gennari 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 | 2014-06-05 |
| Decision Date | 2015-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08034013782037 | K141492 | 000 |
| 18052705496250 | K141492 | 000 |