Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K061129 |
Device Name |
GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 |
Applicant |
GENERAL ELECTRIC CO. |
99000 INNOVATION DRIVE |
WAUWATOSA,
WI
53226
|
|
Applicant Contact |
PATRICIA TAIGE |
Correspondent |
GENERAL ELECTRIC CO. |
99000 INNOVATION DRIVE |
WAUWATOSA,
WI
53226
|
|
Correspondent Contact |
PATRICIA TAIGE |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/24/2006 |
Decision Date | 06/01/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|