OMA · Amplitude-Integrated Electroencephalograph
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | OMA |
|---|---|
| Device Name | Amplitude-Integrated Electroencephalograph |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Classification Rationale
Class II (performance standards).
Cleared Devices (16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192889 | Neo | Eemagine Medical Imaging Solutions GmbH | Jan 30, 2020 | SESE |
| K163644 | Nihon Kohden QP-160AK EEG Trend Program | Nihon Kohden Corporation | May 19, 2017 | SESE |
| K161027 | Cadwell AmpliScan | Cadwell Industries, Inc. | Nov 8, 2016 | SESE |
| K152301 | Background Pattern Classification [BPc(TM)] | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Jun 3, 2016 | SESE |
| K130238 | NIHON KOHDEN AE-918P NEURO UNIT | Nihon Kohden Corp. | Mar 4, 2015 | SESE |
| K131789 | CEREBRALOGIK- AEEG | Mennen Medical , Ltd. | Dec 27, 2013 | SESE |
| K123079 | OLYMPIC BRAINZ MONITOR | Excel-Tech Ltd. (Xltek) | May 8, 2013 | SESE |
| K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P | Nihon Kohden America, Inc. | Mar 16, 2012 | SESE |
| K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | Nihon Kohden America, Inc. | Jul 9, 2010 | SESE |
| K093949 | OLYMPIC BRAINZ MONITOR MODEL OBM70001 | Natus Medical, Inc. | Jun 16, 2010 | SESE |
| K081551 | TWIN NEUROTRAC-III | Astro-Med, Inc. | Dec 24, 2008 | SESE |
| K080217 | COMPONENT NEUROMONITORING SYSTEM | Moberg Research, Inc. | Nov 5, 2008 | SESE |
| K071449 | BRM3 BRAIN MONITOR | Brainz Instruments , Ltd. | Sep 14, 2007 | SESE |
| K031149 | OLYMPIC CFM 6000 | Olympic Medical Corp. | May 14, 2003 | SESE |
| K983229 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM | Olympic Medical Corp. | Mar 23, 1999 | SESE |
| K791580 | CEREBRAL FUNCTION MONITOR 870 | Applied Medical Research | Sep 4, 1979 | SESE |
Top Applicants
- Olympic Medical Corp. — 2 clearances
- Nihon Kohden America, Inc. — 2 clearances
- Nihon Kohden Corporation — 1 clearance
- Nihon Kohden Corp. — 1 clearance
- Natus Medical, Inc. — 1 clearance
