The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Sonoace Sa-8000 Diagnostic Ultrasound System.
| Device ID | K013627 |
| 510k Number | K013627 |
| Device Name: | SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDISON AMERICA, INC. 11075 KNOTT AVE. Cypress, CA 90630 |
| Contact | A. Robert Depalma |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2001-11-16 |
| Summary: | summary |