Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K023720 |
Device Name |
SONOLINE ANTARES ULTRASOUND SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
22010 S.E. 51ST ST. |
ISSAQUAH,
WA
98027 -7002
|
|
Applicant Contact |
JUDI HOFFMAN |
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 | 11/05/2002 |
Decision Date | 11/20/2002 |
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
|
|
|