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 |