The following data is part of a premarket notification filed by The Linden Group Corp with the FDA for Optikview Gup2103cmi.
| Device ID | K191705 |
| 510k Number | K191705 |
| Device Name: | OptikView GUP2103CMI |
| Classification | Display, Diagnostic Radiology |
| Applicant | The Linden Group Corp 2B Wing Drive Cedar Knolls, NJ 07927 |
| Contact | James Chen |
| Correspondent | Marc Leppla Qubyx Software Technologies Inc 501 Silverside Road, Suite 105 Wilmington, DE 19809 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-26 |
| Decision Date | 2020-03-16 |