The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Eub-515 Diagnostic Ultrasound Device.
| Device ID | K897042 |
| 510k Number | K897042 |
| Device Name: | EUB-515 DIAGNOSTIC ULTRASOUND DEVICE |
| 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 | 1989-12-18 |
| Decision Date | 1990-09-13 |