FDA Product Code OLV: Standard Polysomnograph With Electroencephalograph
Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.
Leading manufacturers include Nox Medical Ehf, Compumedics Limited and Somnomedics GmbH.
FDA 510(k) Cleared Standard Polysomnograph With Electroencephalograph Devices (Product Code OLV)
About Product Code OLV - Regulatory Context
510(k) Submission Activity
64 total 510(k) submissions under product code OLV since 1986, with 64 receiving FDA clearance (average review time: 122 days).
Submission volume has increased in recent years - 4 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 OLV have taken an average of 179 days to reach a decision - up from 118 days historically. Manufacturers should account for longer review timelines in current project planning.
OLV devices are reviewed by the Neurology panel. Browse all Neurology devices →