Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K143253 |
Device Name |
O-MAR |
Applicant |
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V. |
VEENPLUIS 4-6 |
BEST,
NL
5684 PC
|
|
Applicant Contact |
JAN VAN DE KERKHOF |
Correspondent |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
595 MINER RD. |
CLEVLAND,
OH
44143
|
|
Correspondent Contact |
SUSAN QUICK |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/13/2014 |
Decision Date | 04/09/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|