Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K191958 |
Device Name |
Aveta System |
Applicant |
Meditrina, Inc. |
1190 Saratoga Avenue, Suite 180 |
San Jose,
CA
95129
|
|
Applicant Contact |
Csaba Truckai |
Correspondent |
Meditrina, Inc. |
1190 Saratoga Avenue, Suite 180 |
San Jose,
CA
95129
|
|
Correspondent Contact |
Csaba Truckai |
Regulation Number | 884.1690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/23/2019 |
Decision Date | 10/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|