The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Eub-40.
| Device ID | K844128 |
| 510k Number | K844128 |
| Device Name: | EUB-40 |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Contact | Richard A Long |
| Correspondent | Richard A Long HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-23 |
| Decision Date | 1985-02-25 |