The following data is part of a premarket notification filed by Ankon Technologies Co., Ltd. with the FDA for Navicam Small Bowel Capsule Endoscopy System.
| Device ID | K221590 |
| 510k Number | K221590 |
| Device Name: | NaviCam Small Bowel Capsule Endoscopy System |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | ANKON Technologies Co., Ltd. B3-2, B3-3, D3-4 Biolake, No.666, Hi-Tech Road Wuhan, CN 430075 |
| Contact | Si Feng Wang |
| Correspondent | Shoshana Friedman ProMedoss Inc 3521 Hatwynn Road Charlotte, NC 28269 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-02 |
| Decision Date | 2022-12-02 |