Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K120221 |
Device Name |
GE ECHOPAC |
Applicant |
GE HEALTHCARE |
9900 W. INNOVATION DRIVE |
RP-2138 |
WAUWATOSA,
WI
53226
|
|
Applicant Contact |
BRYAN BEHN |
Correspondent |
GE HEALTHCARE |
9900 W. INNOVATION DRIVE |
RP-2138 |
WAUWATOSA,
WI
53226
|
|
Correspondent Contact |
BRYAN BEHN |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 01/25/2012 |
Decision Date | 03/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|