Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K041319 |
Device Name |
SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
1230 SHOREBIRE WAY |
P O BOX 7393 |
MOUNTAIN VIEW,
CA
94039 -7393
|
|
Applicant Contact |
ISKRA MRAKOVIC |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
1230 SHOREBIRE WAY |
P O BOX 7393 |
MOUNTAIN VIEW,
CA
94039 -7393
|
|
Correspondent Contact |
ISKRA MRAKOVIC |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/18/2004 |
Decision Date | 06/07/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|