The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Eub-165.
| Device ID | K895326 |
| 510k Number | K895326 |
| Device Name: | EUB-165 |
| Classification | Echocardiograph |
| Applicant | HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Contact | Yakiguchi |
| Correspondent | Yakiguchi HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-29 |
| Decision Date | 1990-03-22 |