The following data is part of a premarket notification filed by Anx Robotica Corp. with the FDA for Intramarx Radiopaque Markers.
| Device ID | K191087 |
| 510k Number | K191087 |
| Device Name: | IntraMarX Radiopaque Markers |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | AnX Robotica Corp. 7213 Regency Court Plano, TX 75204 |
| Contact | Lin Wang |
| Correspondent | Giselle Zhang Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-24 |
| Decision Date | 2019-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850015518058 | K191087 | 000 |
| 00850015518041 | K191087 | 000 |
| 00850015518034 | K191087 | 000 |
| 00850015518140 | K191087 | 000 |
| 00850015518133 | K191087 | 000 |
| 00850015518126 | K191087 | 000 |