Definition: 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 An
| Device Type ID | 3767 |
| Device Name | Standard Polysomnograph With Electroencephalograph |
| Physical State | May Include Standard Polysomnography Recording Hardware (e.g. Headbox, Cables, Computer, Monitor, Wireless) And Basic Software (e.g. Used To Display, Store, Archive, Or Manually Annotate Data). Does NOT Include Electrodes, Vital Signs Monitors, Polys |
| Technical Method | Uses Electrodes Placed On The Scalp, Within The Brain, Or Other Locations, Via User-specified Locations, To Record And Display Electrical Activity Of The Brain And Other Organs |
| Target Area | Brain |
| Regulation Description | Electroencephalograph. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OLV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3767 |
| Device | Standard Polysomnograph With Electroencephalograph |
| Product Code | OLV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electroencephalograph. |
| CFR Regulation Number | 882.1400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NATUS MEDICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEUROTRONICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Overheating Of Device | 1 |
Sparking | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Natus Neurology Inc | II | Jul-28-2018 |