The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Seven Add'l Transducers For The Eub-450 Ultrasound.
| Device ID | K900683 |
| 510k Number | K900683 |
| Device Name: | SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-13 |
| Decision Date | 1990-08-31 |