Home › Device types › OLV
Standard Polysomnograph With Electroencephalograph
FDA product code OLV · Class 2 · Neurology
492
Registered devices
21
Adverse events
1
Recalls
65
510(k) clearances
Devices with this code
Somnostar — Carefusion CorporationSleep Profiler PSG2 — ADVANCED BRAIN MONITORING, INC.Serenity TH01 Thermocouple Sensor, 249 Keyhole, 2.0m — Neurotronics, LLCAlice 6 — Respironics, Inc.Trackit Sleepwalker — LIFELINES LIMITEDSierra Summit — CADWELL INDUSTRIES, INC.BluPRO® — NIHON KOHDEN CORPORATIONAlice 6 — Respironics, Inc.Sleep Profiler PSG2 — ADVANCED BRAIN MONITORING, INC.Somnostar — Carefusion CorporationAlice 6 — Respironics, Inc.Sierra II — CADWELL INDUSTRIES, INC.Onera STS — Onera B.V.Alice 6 — Respironics, Inc.Apollo — CADWELL INDUSTRIES, INC.Alice 6 — Respironics, Inc.Sierra Summit — CADWELL INDUSTRIES, INC.Somnostar — Carefusion CorporationSleep Profiler PSG2 — ADVANCED BRAIN MONITORING, INC.NA — NIHON KOHDEN CORPORATIONSomnostar — Carefusion CorporationSleep Profiler PSG2 — ADVANCED BRAIN MONITORING, INC.Sphinx CU710 Control Unit — Neurotronics, LLCBluPRO® — NIHON KOHDEN AMERICA, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-02-01 | Natus Neurology Inc | Potential to be able to import an ambulatory exam for a patient for which the exam was not started. |
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