Device Classification Name |
Display, Diagnostic Radiology
|
510(k) Number |
K191705 |
Device Name |
OptikView GUP2103CMI |
Applicant |
The Linden Group Corp |
2B Wing Drive |
Cedar Knolls,
NJ
07927
|
|
Applicant Contact |
James Chen |
Correspondent |
Qubyx Software Technologies Inc |
501 Silverside Road, Suite 105 |
Wilmington,
DE
19809
|
|
Correspondent Contact |
Marc Leppla |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 06/26/2019 |
Decision Date | 03/16/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|