The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Mycolor 202 Diagnostic Ultrasound System And Transducers.
| Device ID | K031552 |
| 510k Number | K031552 |
| Device Name: | MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDISON AMERICA, INC. 11075 KNOTT AVE. Cypress, CA 90630 |
| Contact | Bob Depalma |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| 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 | 2003-05-19 |
| Decision Date | 2003-05-30 |
| Summary: | summary |