The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Mysono 201 Diagnostic Ultrasound And Transducers.
| Device ID | K003121 |
| 510k Number | K003121 |
| Device Name: | MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MEDISON AMERICA, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Contact | Gary J Allsebrok |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-10-05 |
| Decision Date | 2000-10-20 |