Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K050034 |
Device Name |
SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
22010 S.E. 51ST ST. |
ISSAQUAH,
WA
98029
|
|
Applicant Contact |
PATRICK LYNCH |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/07/2005 |
Decision Date | 01/13/2005 |
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
|
|
|