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 |