The following data is part of a premarket notification filed by Anx Robotica Corp with the FDA for Navicam Xpress Stomach System.
| Device ID | K203192 |
| 510k Number | K203192 |
| Device Name: | NaviCam Xpress Stomach System |
| Classification | Magnetically Maneuvered Capsule Endoscopy System |
| Applicant | AnX Robotica Corp 1047 Serpentine Lane Pleasanton, CA 94566 |
| Contact | Shoshana (shosh) Friedman |
| Correspondent | Shoshana (shosh) Friedman AnX Robotica Corp 1047 Serpentine Lane Pleasanton, CA 94566 |
| Product Code | QKZ |
| CFR Regulation Number | 876.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-28 |
| Decision Date | 2021-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850015518294 | K203192 | 000 |