The following data is part of a premarket notification filed by Dideco S.r.l. with the FDA for Ecc.o System.
| Device ID | K050890 |
| 510k Number | K050890 |
| Device Name: | ECC.O SYSTEM |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | DIDECO S.R.L. 195 WEST ST. Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall DIDECO S.R.L. 195 WEST ST. Waltham, MA 02451 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-08 |
| Decision Date | 2005-05-05 |
| Summary: | summary |