The following data is part of a premarket notification filed by Anx Robotica Corp. with the FDA for Intramarx 3d Radiopaque Marker.
| Device ID | K201106 |
| 510k Number | K201106 |
| Device Name: | IntraMarX 3D Radiopaque Marker |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | AnX Robotica Corp. 1047 Serpentine Ln. Suite 100, Pleasanton Pleasanton, CA 94566 |
| Contact | Steven Gu |
| Correspondent | Randy Jiang Emergo Global Consulting, LLC 2500 Bee Cave Rd, Bldg 1, Suite 300 Austin, TX 78746 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-24 |
| Decision Date | 2020-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850015518171 | K201106 | 000 |
| 00850015518164 | K201106 | 000 |
| 00850015518157 | K201106 | 000 |
| 00850015518232 | K201106 | 000 |