Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K072075 |
Device Name |
MODIFICATION TO GE LOGIQ A3 |
Applicant |
GENERAL ELECTRIC CO. |
9900 INNOVATION DRIVE |
MAIL CODE: RP-2138 |
WAUWATOSA,
WI
53226
|
|
Applicant Contact |
ALLEN SCHUH |
Correspondent |
GENERAL ELECTRIC CO. |
9900 INNOVATION DRIVE |
MAIL CODE: RP-2138 |
WAUWATOSA,
WI
53226
|
|
Correspondent Contact |
ALLEN SCHUH |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/30/2007 |
Decision Date | 08/29/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|