The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Eub-6000 Ultrasound Diagnostic Scanner.
| Device ID | K994026 |
| 510k Number | K994026 |
| Device Name: | EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI MEDICAL CORP. OF AMERICA 19030 PORTOS DR. Saratoga, CA 95070 |
| Contact | Charles F Hottinger |
| Correspondent | Charles F Hottinger HITACHI MEDICAL CORP. OF AMERICA 19030 PORTOS DR. Saratoga, CA 95070 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-26 |
| Decision Date | 2000-03-29 |
| Summary: | summary |