The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Sdl-300.
| Device ID | K854337 |
| 510k Number | K854337 |
| Device Name: | SDL-300 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
| Contact | Takao Someyama |
| Correspondent | Takao Someyama SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto City 604 Japan, JP |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-28 |
| Decision Date | 1986-06-20 |