The following data is part of a premarket notification filed by Convida Healthcare & Systems Corporation with the FDA for Vida Led Surgical Lighting System, V Series.
Device ID | K140930 |
510k Number | K140930 |
Device Name: | VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES |
Classification | Light, Surgical, Ceiling Mounted |
Applicant | CONVIDA HEALTHCARE & SYSTEMS CORPORATION NO. 33, DINGHU ROAD, GUISHAN TOWNSHIP Taoyuan County, TW 33378 |
Contact | Sharon Lee |
Correspondent | Sharon Lee CONVIDA HEALTHCARE & SYSTEMS CORPORATION NO. 33, DINGHU ROAD, GUISHAN TOWNSHIP Taoyuan County, TW 33378 |
Product Code | FSY |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-11 |
Decision Date | 2014-06-09 |
Summary: | summary |