Device Classification Name |
System, Gastrointestinal Motility (Electrical)
|
510(k) Number |
K201106 |
Device Name |
IntraMarX 3D Radiopaque Marker |
Applicant |
AnX Robotica Corp. |
1047 Serpentine Ln. Suite 100, Pleasanton |
Pleasanton,
CA
94566
|
|
Applicant Contact |
Steven Gu |
Correspondent |
Emergo Global Consulting, LLC |
2500 Bee Cave Rd, Bldg 1, Suite 300 |
Austin,
TX
78746
|
|
Correspondent Contact |
Randy Jiang |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 04/24/2020 |
Decision Date | 05/21/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|