Amplitude-Integrated Electroencephalograph
Regulation 882.1400
0510(k)s in 12 months (16 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in OMA
| Company | 510(k)s | Recalls |
|---|---|---|
| Moberg Research, Inc. | 1 | 1 |
| Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | 0 | 2 |
| Nihon Kohden Corp. | 2 | 0 |
| Nihon Kohden America, Inc. | 2 | 0 |
| Olympic Medical Corp. | 2 | 0 |
| Applied Medical Research | 1 | 0 |
| Astro-Med, Inc. | 1 | 0 |
| Brainz Instruments , Ltd. | 1 | 0 |
| Cadwell Industries, Inc. | 1 | 0 |
| Eemagine Medical Imaging Solutions GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 30, 2020 | K192889 | Neo Eemagine Medical Imaging Solutions GmbH, DE | OMA |
| May 19, 2017 | K163644 | Nihon Kohden QP-160AK EEG Trend Program Nihon Kohden Corporation, JP | OMA |
| Nov 8, 2016 | K161027 | Cadwell AmpliScan Cadwell Industries, Inc. | OMA |
| Jun 3, 2016 | K152301 | Background Pattern Classification [BPc(TM)] Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | OMA |
| Mar 4, 2015 | K130238 | NIHON KOHDEN AE-918P NEURO UNIT Nihon Kohden Corp. | OMA |
| Dec 27, 2013 | K131789 | CEREBRALOGIK- AEEG Mennen Medical , Ltd., IL | OMA |
| May 8, 2013 | K123079 | OLYMPIC BRAINZ MONITOR Excel-Tech Ltd. (Xltek), CA | OMA |
| Mar 16, 2012 | K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P Nihon Kohden America, Inc. | OMA |
| Jul 9, 2010 | K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM Nihon Kohden America, Inc. | OMA |
| Jun 16, 2010 | K093949 | OLYMPIC BRAINZ MONITOR MODEL OBM70001 Natus Medical, Inc., CA | OMA |
| Dec 24, 2008 | K081551 | TWIN NEUROTRAC-III Astro-Med, Inc. | OMA |
| Nov 5, 2008 | K080217 | COMPONENT NEUROMONITORING SYSTEM Moberg Research, Inc. | OMA |
| Sep 14, 2007 | K071449 | BRM3 BRAIN MONITOR Brainz Instruments , Ltd., NZ | OMA |
| May 14, 2003 | K031149 | OLYMPIC CFM 6000 Olympic Medical Corp. | OMA |
| Mar 23, 1999 | K983229 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM Olympic Medical Corp. | OMA |
| Sep 4, 1979 | K791580 | CEREBRAL FUNCTION MONITOR 870 Applied Medical Research | OMA |
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