FDA 510(k) Applications for Medical Device Product Code "OMA"
(Amplitude-Integrated Electroencephalograph)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K081551 | ASTRO-MED, INC. | TWIN NEUROTRAC-III | 12/24/2008 |
| K071449 | BRAINZ INSTRUMENTS LTD. | BRM3 BRAIN MONITOR | 09/14/2007 |
| K161027 | Cadwell Industries, Inc. | Cadwell AmpliScan | 11/08/2016 |
| K192889 | eemagine Medical Imaging Solutions GmbH | Neo | 01/30/2020 |
| K123079 | EXCEL-TECH LTD. (XLTEK) | OLYMPIC BRAINZ MONITOR | 05/08/2013 |
| K131789 | MENNEN MEDICAL LTD. | CEREBRALOGIK- AEEG | 12/27/2013 |
| K080217 | MOBERG RESEARCH, INC. | COMPONENT NEUROMONITORING SYSTEM | 11/05/2008 |
| K152301 | Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) | Background Pattern Classification [BPc(TM)] | 06/03/2016 |
| K093949 | NATUS MEDICAL, INC. | OLYMPIC BRAINZ MONITOR MODEL OBM70001 | 06/16/2010 |
| K120485 | NIHON KOHDEN AMERICA, INC. | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P | 03/16/2012 |
| K092573 | NIHON KOHDEN AMERICA, INC. | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | 07/09/2010 |
| K130238 | NIHON KOHDEN CORP. | NIHON KOHDEN AE-918P NEURO UNIT | 03/04/2015 |
| K163644 | Nihon Kohden Corporation | Nihon Kohden QP-160AK EEG Trend Program | 05/19/2017 |
| K031149 | OLYMPIC MEDICAL CORP. | OLYMPIC CFM 6000 | 05/14/2003 |
| K983229 | OLYMPIC MEDICAL CORP. | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM | 03/23/1999 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
