Device Classification Name |
Display, Diagnostic Radiology
|
510(k) Number |
K152847 |
Device Name |
DIVA ZSP5812CMI with QUBYX PerfectLum bundle |
Applicant |
QUBYX LTD. |
80, RUE MARECHAL JOFFRE |
NICE,
FR
06000
|
|
Applicant Contact |
MARC LEPPLA |
Correspondent |
QUBYX LTD. |
80, RUE MARECHAL JOFFRE |
NICE,
FR
06000
|
|
Correspondent Contact |
MARC LEPPLA |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/29/2015 |
Decision Date | 11/17/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|