Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K130739 |
Device Name |
ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
685 East Middlefield Road |
Mountain View,
CA
94043
|
|
Applicant Contact |
SHELLY PEARCE |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
685 East Middlefield Road |
Mountain View,
CA
94043
|
|
Correspondent Contact |
SHELLY PEARCE |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/18/2013 |
Decision Date | 06/06/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|