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 |