The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Eub-8000.
| Device ID | K954220 |
| 510k Number | K954220 |
| Device Name: | EUB-8000 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI MEDICAL CORP. OF AMERICA 660 WHITE PLAINS RD. Tarrytown, NY 10591 |
| Contact | Charles F Hottinger |
| Correspondent | Charles F Hottinger HITACHI MEDICAL CORP. OF AMERICA 660 WHITE PLAINS RD. Tarrytown, NY 10591 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-11 |
| Decision Date | 1997-05-07 |
| Summary: | summary |