Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K132736 |
Device Name |
ACCURO 3000 ULTRASOUND SCANNER |
Applicant |
RIVANNA MEDICAL, LLC |
1304 STONEGATE CT. |
CROZET,
VA
22932
|
|
Applicant Contact |
WILLIAM MAULDIN |
Correspondent |
RIVANNA MEDICAL, LLC |
1304 STONEGATE CT. |
CROZET,
VA
22932
|
|
Correspondent Contact |
WILLIAM MAULDIN |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/03/2013 |
Decision Date | 03/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|