The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Eub-315.
| Device ID | K905294 |
| 510k Number | K905294 |
| Device Name: | EUB-315 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Contact | Takiguchi |
| Correspondent | Takiguchi HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-27 |
| Decision Date | 1991-02-25 |