The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Shimasonic Sdu-350 Electronic Linear/convex Diagnostic Ultrasound System.
Device ID | K953634 |
510k Number | K953634 |
Device Name: | SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Contact | Yashuharu Ishii |
Correspondent | Yashuharu Ishii 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 | 1995-08-02 |
Decision Date | 1996-02-13 |