The following data is part of a premarket notification filed by Scivita Medical Technology Co., Ltd. with the FDA for 4k Uhd Camera System.
| Device ID | K200216 |
| 510k Number | K200216 |
| Device Name: | 4K UHD Camera System |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | Scivita Medical Technology Co., Ltd. No.8, ZhongTian Xiang, Suzhou Industrial Park Suzhou, CN 215000 |
| Contact | Ruqin Wu |
| Correspondent | Diana Hong Mid-Link Consulting Co, Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | HET |
| Subsequent Product Code | EOB |
| Subsequent Product Code | FET |
| Subsequent Product Code | FGB |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | HRX |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-28 |
| Decision Date | 2020-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971381250091 | K200216 | 000 |
| 06971381250060 | K200216 | 000 |