Device Classification Name |
Transducer, Ultrasonic, Diagnostic
|
510(k) Number |
K122515 |
Device Name |
C2-9-D ULTRASOUND TRANSDUCER |
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 | 892.1570
|
Classification Product Code |
|
Date Received | 08/17/2012 |
Decision Date | 09/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|