Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K121329 |
Device Name |
AIXPLORER |
Applicant |
SUPERSONIC IMAGINE |
510 RUE RENE DESCARTES |
AIX-EN-PROVENCE,
FR
13857
|
|
Applicant Contact |
JACQUES SOUQUET |
Correspondent |
SUPERSONIC IMAGINE |
510 RUE RENE DESCARTES |
AIX-EN-PROVENCE,
FR
13857
|
|
Correspondent Contact |
JACQUES SOUQUET |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/02/2012 |
Decision Date | 08/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|