Diopsys, Inc.

Medical device manufacturer in Pine Brook, NJ.

2510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K101763Diopsys Nova Vep Vision Testing SystemGWE · Traditional 05/09/2011SE
K043491EnfanttmGWE · Traditional 03/16/2005SE

Recalls

RecallProductInitiated
Z-1437-2010 Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC…The computer based system may lose test counts when the time in the device was changed during a changeover… 04/02/2007Terminated