Device Classification Name |
system, gastrointestinal motility (electrical)
|
510(k) Number |
K191087 |
Device Name |
IntraMarX Radiopaque Markers |
Applicant |
AnX Robotica Corp. |
7213 Regency Court |
Plano,
TX
75204
|
|
Applicant Contact |
Lin Wang |
Correspondent |
Emergo Global Consulting, LLC |
2500 Bee Cave Road, Building 1, Suite 300 |
Austin,
TX
78746
|
|
Correspondent Contact |
Giselle Zhang |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 04/24/2019 |
Decision Date | 12/18/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|