The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Mysono U5 Diagnostic Ultrasound System.
Device ID | K100186 |
510k Number | K100186 |
Device Name: | MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | MEDISON CO., LTD. 1394 25TH STREET NW Buffalo, MN 55313 |
Contact | Mark Job |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
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 | Yes |
Combination Product | No |
Date Received | 2010-01-22 |
Decision Date | 2010-03-24 |
Summary: | summary |