The following data is part of a premarket notification filed by Esaote Biomedica Spa with the FDA for Monitor, Model 2817.
| Device ID | K902334 |
| 510k Number | K902334 |
| Device Name: | MONITOR, MODEL 2817 |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | ESAOTE BIOMEDICA SPA C/O PAREXEL INTERNATIONAL CORP ONE ALEWIFE PLACE Cambridge, MA 02140 |
| Contact | Barry Sall |
| Correspondent | Barry Sall ESAOTE BIOMEDICA SPA C/O PAREXEL INTERNATIONAL CORP ONE ALEWIFE PLACE Cambridge, MA 02140 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-24 |
| Decision Date | 1990-06-26 |