Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K140138 |
Device Name |
HEARTNAVIGATOR RELEASE 2.0 |
Applicant |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
3959 VAN DYKE ROAD, SUITE 245 |
LUTZ,
FL
33558
|
|
Applicant Contact |
MICHAEL DAYTON |
Correspondent |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
3959 VAN DYKE ROAD, SUITE 245 |
LUTZ,
FL
33558
|
|
Correspondent Contact |
MICHAEL DAYTON |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/22/2014 |
Decision Date | 06/10/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|