Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K111582 |
Device Name |
LOGIQ S8 |
Applicant |
GE HEALTHCARE |
9900 INNOVATION DRIVE |
MAIL STOP RP-2138 |
WAUWATOSA,
WI
53226
|
|
Applicant Contact |
BRYAN BEHN |
Correspondent |
GE HEALTHCARE |
9900 INNOVATION DRIVE |
MAIL STOP RP-2138 |
WAUWATOSA,
WI
53226
|
|
Correspondent Contact |
BRYAN BEHN |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/06/2011 |
Decision Date | 07/26/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|