The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Sa8000 Se Diagnostic Ultrasound System.
| Device ID | K043455 |
| 510k Number | K043455 |
| Device Name: | SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDISON CO., LTD. 1600 MANCHESTER WAY Corinth, TX |
| Contact | Carl Alletto |
| Correspondent | N.e. Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| 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 | 2004-12-15 |
| Decision Date | 2004-12-21 |
| Summary: | summary |