Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K101878 |
Device Name |
GE LOGIQ P5 MODEL H44662LD |
Applicant |
GE HEALTHCARE |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
BRYAN BEHN |
Correspondent |
GE HEALTHCARE |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
BRYAN BEHN |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/06/2010 |
Decision Date | 08/31/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|