The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Sonoace 6000/ Ultramark 400.
| Device ID | K981510 |
| 510k Number | K981510 |
| Device Name: | SONOACE 6000/ ULTRAMARK 400 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton, CA 94588 |
| Correspondent | Carole Stamp 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 | 1998-04-28 |
| Decision Date | 1998-05-08 |
| Summary: | summary |