The following data is part of a premarket notification filed by Convida Healthcare & Systems Corporation with the FDA for Vida Led Surgical Lighting System.
| Device ID | K132307 |
| 510k Number | K132307 |
| Device Name: | VIDA LED SURGICAL LIGHTING SYSTEM |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | CONVIDA HEALTHCARE & SYSTEMS CORPORATION 2F AND B2, NO.33, DINGHU RD GUISHAN TOWNSHIP Taoyuan County, TW 33378 |
| Contact | Ryan Hung |
| Correspondent | Ryan Hung CONVIDA HEALTHCARE & SYSTEMS CORPORATION 2F AND B2, NO.33, DINGHU RD 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 | 2013-07-24 |
| Decision Date | 2013-11-05 |
| Summary: | summary |