Device Classification Name |
Transducer, Ultrasonic, Diagnostic
|
510(k) Number |
K160806 |
Device Name |
Verza Guidance System |
Applicant |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
102 FIRST ST. SOUTH |
KALONA,
IA
52247
|
|
Applicant Contact |
Amanda Stahle |
Correspondent |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
102 FIRST ST. SOUTH |
KALONA,
IA
52247
|
|
Correspondent Contact |
Amanda Stahle |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 03/24/2016 |
Decision Date | 08/05/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|