The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Echo View/shimasonic Diagnostic Ultrasound System, Model Sdu-2200.
Device ID | K003514 |
510k Number | K003514 |
Device Name: | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Contact | Masaaki Shibata |
Correspondent | Masaaki Shibata SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-14 |
Decision Date | 2001-02-12 |