1 device · 1 company · 2025
Product code OLV: Standard Polysomnograph With Electroencephalograph
1 device under product code OLV, 2025, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Standard Polysomnograph With Electroencephalograph. 21 CFR 882.1400, Class II. 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. MAUDE held 21 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Falcon HSTK242447 · 510(k) | Compumedics Limited | Neurology | database entry |
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