The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Sa 9900 Plus Diagnostic Ultrasound System.
| Device ID | K032329 |
| 510k Number | K032329 |
| Device Name: | SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDISON AMERICA, INC. 11075 KNOTT AVE. Cypress, CA 90630 |
| Contact | A. Robert Depalma |
| 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 | 2003-07-29 |
| Decision Date | 2003-08-06 |
| Summary: | summary |