The following data is part of a premarket notification filed by Shimadzu Medical Systems with the FDA for Echoview / Shimasonic Diagnostic Ultrasound Device, Model Sdu-2200pro.
Device ID | K071287 |
510k Number | K071287 |
Device Name: | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Contact | Don Karle |
Correspondent | Don Karle SHIMADZU MEDICAL SYSTEMS 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Product Code | ITX |
Subsequent Product Code | IYN |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-08 |
Decision Date | 2008-01-09 |
Summary: | summary |