The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Eub-405.
| Device ID | K924126 |
| 510k Number | K924126 |
| Device Name: | EUB-405 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg, OH 44087 |
| Contact | Jochen Rogers |
| Correspondent | Jochen Rogers HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg, OH 44087 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-17 |
| Decision Date | 1992-12-10 |