Definition: Measure And Record Electrical Activity Of The Brain By Acquisition Of Amplitude-integrated Electroencephalograph (electroencephalograph Signals That Have Been Filtered And Displayed In A Specific Manner).
| Device Type ID | 3772 |
| Device Name | Amplitude-integrated Electroencephalograph |
| Physical State | May Include Standard Electroencephalograph 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, More Complex Software |
| Technical Method | Uses A Specific Combination Of Filters, A Semi-logarithmic Scale And Bipolar Electrode Placements (via User-specified And/or Sponsor-specified Locations), To Record And Display Electrical Activity Of The Brain. |
| 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 | OMA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3772 |
| Device | Amplitude-integrated Electroencephalograph |
| Product Code | OMA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electroencephalograph. |
| CFR Regulation Number | 882.1400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CADWELL INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NATUS MEDICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIHON KOHDEN CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |