The following data is part of a premarket notification filed by Hitachi Medical Corp. with the FDA for Modifications To Eub-525 Diagnostic Ultrasound Scanner; Eub-2000 Diagnostic Ultrasound Scanner; Sp-711 Sonoprobe System.
| Device ID | K012239 |
| 510k Number | K012239 |
| Device Name: | MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HITACHI MEDICAL CORP. 660 WHITE PLAINS RD. Tarrytown, NY 10591 -5107 |
| Contact | Walter Weyburne |
| Correspondent | Walter Weyburne HITACHI MEDICAL CORP. 660 WHITE PLAINS RD. Tarrytown, NY 10591 -5107 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-17 |
| Decision Date | 2001-08-10 |
| Summary: | summary |