The following data is part of a premarket notification filed by Hitachi Medical Corp. with the FDA for Eub-555.
| Device ID | K926209 |
| 510k Number | K926209 |
| Device Name: | EUB-555 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | HITACHI MEDICAL CORP. 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Contact | Takiguchi |
| Correspondent | Takiguchi HITACHI MEDICAL CORP. 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 | 1992-12-09 |
| Decision Date | 1994-06-03 |