Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K032111 |
Device Name |
ACUSON CV70 CARDIOVASCULAR SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
22010 S.E. 51ST ST. |
ISSAQUAH,
WA
98029 -7298
|
|
Applicant Contact |
CAREY CHAVEZ |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/09/2003 |
Decision Date | 07/18/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|