Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K121781 |
Device Name |
ECHONAVIGATOR RELEASE 1 |
Applicant |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
VEENPLUIS 4-6 |
BEST,
NL
5684 PC
|
|
Applicant Contact |
FRANS JACOBS |
Correspondent |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
VEENPLUIS 4-6 |
BEST,
NL
5684 PC
|
|
Correspondent Contact |
FRANS JACOBS |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 06/18/2012 |
Decision Date | 10/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|