The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Shimasonic Sdu-400 Electronic Linear/convex D.u.s..
| Device ID | K931021 |
| 510k Number | K931021 |
| Device Name: | SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Yuji Shimizu |
| Correspondent | Yuji Shimizu SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-01 |
| Decision Date | 1994-11-14 |