Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K162148 |
Device Name |
Allura Xper R9 |
Applicant |
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
VEENPLUIS 4-6 |
BEST,
NL
5684PC
|
|
Applicant Contact |
Jeanette Becker |
Correspondent |
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
VEENPLUIS 4-6 |
BEST,
NL
5684PC
|
|
Correspondent Contact |
Jeanette Becker |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/01/2016 |
Decision Date | 11/23/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|