Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K181437 |
Device Name |
Pure Vu System |
Applicant |
Motus GI Medical Technologies Ltd. |
22 Keren Ha'yesod St. |
Tirat Carmel,
IL
3902638
|
|
Applicant Contact |
Hagit Ephrath |
Correspondent |
Motus GI Medical Technologies Ltd. |
22 Keren Ha'yesod St. |
Tirat Carmel,
IL
3902638
|
|
Correspondent Contact |
Hagit Ephrath |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/01/2018 |
Decision Date | 06/21/2018 |
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
|
|
|