De Novo DEN130051

Device: PEDIATRIC VISION SCANNER
Contact: justin g shaka
De Novo number: DEN130051
Product code: PMW
Regulation: 886.1342
Classification name: strabismus detection device
Decision: granted (DENG)
Decision date: 2016-06-08
Date received: 2013-12-13
Classification advisory: Ophthalmic
Review advisory: Ophthalmic
Type: Direct

Current FDA Classification#

Product code: PMW
Device name: Strabismus Detection Device
Medical specialty: Ophthalmic
Device class: 2
Regulation: 886.1342
Implant: N
Life sustain/support: N