The following data is part of a premarket notification filed by Foshan Coxo Medical Instrument Co., Ltd. with the FDA for Root Apex Locator.
| Device ID | K212178 |
| 510k Number | K212178 |
| Device Name: | Root Apex Locator |
| Classification | Locator, Root Apex |
| Applicant | Foshan COXO Medical Instrument Co., Ltd. BLDG 4, District A, Guangdong New Light Source Industrial Base, South Of Luocun Avenue, Nanhai District Foshan, CN 528226 |
| Contact | Yongjian Zheng |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5 YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-12 |
| Decision Date | 2022-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974267890442 | K212178 | 000 |