510(k) K983229
- Device
- OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM
- Applicant
- OLYMPIC MEDICAL CORP.
- 510(k) number
- K983229
- Product code
- OMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-03-23
- Date received
- 1998-09-15
- Regulation
- 882.1400
- Classification name
- Amplitude-integrated Electroencephalograph
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDWARD (TED) B WEILER
- Address
- 5900 First Ave. S. Seattle WA US 98108 98108
FDA Registration Numbers#
- 3007611554
- 3015929663
- 3017374042
- 3005581270
- 3010611950
- 9612330
- 8030229
- 2080783
- 3023164
- 2031720
- 9612389
- 9611252
- 3016852448
- 3013501110
Source Documents#
Other 510(k) Records For Product Code OMA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192889 | Neo | Eemagine Medical Imaging Solutions GmbH | 2020-01-30 |
| K163644 | Nihon Kohden QP-160AK EEG Trend Program | Nihon Kohden Corporation | 2017-05-19 |
| K161027 | Cadwell AmpliScan | Cadwell Industries, Inc. | 2016-11-08 |
| K152301 | Background Pattern Classification [BPc(TM)] | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-06-03 |
| K130238 | NIHON KOHDEN AE-918P NEURO UNIT | Nihon Kohden Corp. | 2015-03-04 |
| K131789 | CEREBRALOGIK- AEEG | Mennen Medical , Ltd. | 2013-12-27 |
| K123079 | OLYMPIC BRAINZ MONITOR | Excel-Tech Ltd. (Xltek) | 2013-05-08 |
| 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 |
| K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | Nihon Kohden America, Inc. | 2010-07-09 |
| K093949 | OLYMPIC BRAINZ MONITOR MODEL OBM70001 | Natus Medical, Inc. | 2010-06-16 |
| K081551 | TWIN NEUROTRAC-III | Astro-Med, Inc. | 2008-12-24 |
| K080217 | COMPONENT NEUROMONITORING SYSTEM | Moberg Research, Inc. | 2008-11-05 |
| K071449 | BRM3 BRAIN MONITOR | Brainz Instruments , Ltd. | 2007-09-14 |
| K031149 | OLYMPIC CFM 6000 | Olympic Medical Corp. | 2003-05-14 |
| K791580 | CEREBRAL FUNCTION MONITOR 870 | Applied Medical Research | 1979-09-04 |
Legacy Summary#
summary
FDA Review#
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