The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Sonoace 5500 Diagnostic Ultrasound System.
| Device ID | K992761 |
| 510k Number | K992761 |
| Device Name: | SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton, CA 94588 |
| Contact | Moon T Kwon |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-08-17 |
| Decision Date | 1999-09-01 |
| Summary: | summary |