The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Additional Transducers For Use With Sdu 500.
| Device ID | K896644 |
| 510k Number | K896644 |
| Device Name: | ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SHIMADZU CORP. 101 W. WALNUT ST. Gardena, CA 90248 |
| Contact | Hiroji Kanamori |
| Correspondent | Hiroji Kanamori SHIMADZU CORP. 101 W. WALNUT ST. Gardena, CA 90248 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-24 |
| Decision Date | 1990-08-21 |