Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K001400 |
Device Name |
ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
22010 S.E. 51ST ST. |
ISSAQUAH,
WA
98029 -7298
|
|
Applicant Contact |
JUDI HOFFMAN |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
22010 S.E. 51ST ST. |
ISSAQUAH,
WA
98029 -7298
|
|
Correspondent Contact |
JUDI HOFFMAN |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/03/2000 |
Decision Date | 08/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|