The following data is part of a premarket notification filed by Hitachi Medical Corp. with the FDA for Transducers, Eup-c318/v33/f334/cc331/b31/032t.
| Device ID | K910268 |
| 510k Number | K910268 |
| Device Name: | TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HITACHI MEDICAL CORP. 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Contact | Takiguchi |
| Correspondent | Takiguchi HITACHI MEDICAL CORP. 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 | 1991-01-15 |
| Decision Date | 1991-04-15 |