The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Echo View/shimasonic Diagnostic Ultrasound System.
Device ID | K970508 |
510k Number | K970508 |
Device Name: | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Contact | Yasuharu Ishii |
Correspondent | Yasuharu 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 | 1997-02-10 |
Decision Date | 1997-08-04 |