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Standard Polysomnograph With Electroencephalograph

FDA product code OLV · Class 2 · Neurology

460
Registered devices
21
Adverse events
1
Recalls
64
510(k) clearances

Devices with this code

Somnostar — Carefusion CorporationNA — NIHON KOHDEN AMERICA, INC.Cascade Elite — CADWELL INDUSTRIES, INC.Nihon Kohden, EEG-1200A Series Neurofax — NIHON KOHDEN CORPORATIONNeurovirtual — M F Equipamentos Medicos Ltda EppSierra Wave — CADWELL INDUSTRIES, INC.Compumedics Falcon — COMPUMEDICS LIMITEDSomnostar — Carefusion CorporationCERVELLO 64 — BLACKROCK NEUROMED, LLCAlice 6 — Respironics, Inc.LTV — VYAIRE MEDICAL, INC.Sleep Profiler — ADVANCED BRAIN MONITORING, INC.Serenity TH01 Thermocouple Sensor, 1.5mm DIN, 2.0m — Neurotronics, LLCTrackit Sleepwalker — LIFELINES LIMITEDBluPRO® — NIHON KOHDEN AMERICA, INC.Neurovirtual — NEUROVIRTUAL USA, INC.Somnostar — Carefusion CorporationSomnostar — Carefusion CorporationTrackit Sleepwalker — LIFELINES LIMITEDNA — NIHON KOHDEN CORPORATIONNeurovirtual — M F Equipamentos Medicos Ltda EppX8 — ADVANCED BRAIN MONITORING, INC.Somnostar — Carefusion CorporationAlice 6 — Respironics, Inc.

Recent recalls

DateFirmReason
2018-02-01Natus Neurology IncPotential to be able to import an ambulatory exam for a patient for which the exam was not started.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.