FDA Product Code GWN: Nystagmograph
Leading manufacturers include Neurobit Technologies Co., Ltd., Natus Medical Denmark Aps and Inventis S.R.L..
FDA 510(k) Cleared Nystagmograph Devices (Product Code GWN)
About Product Code GWN - Regulatory Context
510(k) Submission Activity
59 total 510(k) submissions under product code GWN since 1981, with 59 receiving FDA clearance (average review time: 151 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under GWN have taken an average of 195 days to reach a decision - up from 149 days historically. Manufacturers should account for longer review timelines in current project planning.
GWN devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →