FDA Product Code
FDA Product Code OMA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1400
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192889 | Neo | Eemagine Medical Imaging Solutions GmbH | 2020-01-30 | Traditional | PDF ↗ |
| K163644 | Nihon Kohden QP-160AK EEG Trend Program | Nihon Kohden Corporation | 2017-05-19 | Traditional | PDF ↗ |
| K161027 | Cadwell AmpliScan | Cadwell Industries, Inc. | 2016-11-08 | Traditional | PDF ↗ |
| K152301 | Background Pattern Classification [BPc(TM)] | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-06-03 | Traditional | PDF ↗ |
| K130238 | NIHON KOHDEN AE-918P NEURO UNIT | Nihon Kohden Corp. | 2015-03-04 | Traditional | PDF ↗ |
| K131789 | CEREBRALOGIK- AEEG | Mennen Medical , Ltd. | 2013-12-27 | Traditional | PDF ↗ |
| K123079 | OLYMPIC BRAINZ MONITOR | Excel-Tech Ltd. (Xltek) | 2013-05-08 | Traditional | PDF ↗ |
| K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P | Nihon Kohden America, Inc. | 2012-03-16 | Special | PDF ↗ |
| K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | Nihon Kohden America, Inc. | 2010-07-09 | Traditional | PDF ↗ |
| K093949 | OLYMPIC BRAINZ MONITOR MODEL OBM70001 | Natus Medical, Inc. | 2010-06-16 | Traditional | PDF ↗ |
| K081551 | TWIN NEUROTRAC-III | Astro-Med, Inc. | 2008-12-24 | Traditional | PDF ↗ |
| K080217 | COMPONENT NEUROMONITORING SYSTEM | Moberg Research, Inc. | 2008-11-05 | Traditional | PDF ↗ |
| K071449 | BRM3 BRAIN MONITOR | Brainz Instruments , Ltd. | 2007-09-14 | Traditional | PDF ↗ |
| K031149 | OLYMPIC CFM 6000 | Olympic Medical Corp. | 2003-05-14 | Special | PDF ↗ |
| K983229 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM | Olympic Medical Corp. | 1999-03-23 | Traditional | PDF ↗ |
| K791580 | CEREBRAL FUNCTION MONITOR 870 | Applied Medical Research | 1979-09-04 | Traditional | PDF ↗ |
Product code OMA · Class II · Neurology. Data: openFDA.