Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K032114 |
Device Name |
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
1230 SHOREBIRD WAY |
P O BOX 7393 |
MOUNTAIN VIEW,
CA
94039 -7393
|
|
Applicant Contact |
JERRY W TSUTSUMI |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
LAURA DANIELSON |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/09/2003 |
Decision Date | 07/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|