Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K160182 |
Device Name |
LOGIQ S7 Expert |
Applicant |
GE Healthcare |
9900 Innovation Dr. |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
Bryan Behn |
Correspondent |
GE Healthcare |
9900 Innovation Dr. |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
Bryan Behn |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/27/2016 |
Decision Date | 02/26/2016 |
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
|
|
|