Device Classification Name |
display, diagnostic radiology
|
510(k) Number |
K160328 |
Device Name |
DIVA ZSP2105CMI with QUBYX PerfectLum bundle |
Applicant |
THE LINDEN GROUP CORP. |
2B WING DR |
CEDAR KNOLLS,
NJ
07927 1020
|
|
Applicant Contact |
ROBERT COLAIZZO |
Correspondent |
QUBYX LTD. |
80, RUE MARECHAL JOFFRE |
NICE,
FR
06000
|
|
Correspondent Contact |
MARC LEPPLA |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 02/05/2016 |
Decision Date | 02/25/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|