The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Sonoview Pro By Medison Co., Ltd..
| Device ID | K031886 |
| 510k Number | K031886 |
| Device Name: | SONOVIEW PRO BY MEDISON CO., LTD. |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDISON CO., LTD. 1100 LAKEVIEW BLVD. Denton, TX 76208 |
| Contact | Carl Alletto |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-06-18 |
| Decision Date | 2003-06-30 |
| Summary: | summary |