The following data is part of a premarket notification filed by Eurosets S.r.l. with the FDA for Amg Pmp Infant.
| Device ID | K202510 |
| 510k Number | K202510 |
| Device Name: | AMG PMP Infant |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Eurosets S.r.l. Strada Statale 12, N°143 Medolla, IT I-41036 |
| Contact | Katia Vescovini |
| Correspondent | Katia Vescovini Eurosets S.r.l. Strada Statale 12, N°143 Medolla, IT I-41036 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-31 |
| Decision Date | 2021-12-10 |