510(k) K905594
- Device
- NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300
- Applicant
- NIHON KOHDEN AMERICA, INC.
- 510(k) number
- K905594
- Product code
- GWK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-06-28
- Date received
- 1990-12-13
- Regulation
- 882.1845
- Classification name
- Conditioner, Signal, Physiological
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BILL ABRAMS
- Address
- 17112 Armstrong Ave. Irvine CA US 92714 92714
FDA Registration Numbers#
- 3007323246
- 3007485597
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GWK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060919 | ACTICAL | Respironics, Inc. | 2006-09-22 |
| K061870 | VITALSENSE XHR | Respironics, Inc. | 2006-08-31 |
| K052489 | ACTIHEART | Respironics, Inc. | 2005-09-27 |
| K991045 | MINI-LOGGER SERIES 2000 | Mini-Mitter Co., Inc. | 1999-09-21 |
| K904328 | VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM | Telediagnostic Systems, Inc. | 1991-06-18 |
| K896164 | ASC-954 INTEGRATOR AMPLIFIER | Astro-Med, Inc. | 1990-01-22 |
| K882599 | NICOLET BRAINLAB SYSTEM | Nicolet Instrument Corp. | 1988-10-19 |
| K872290 | BIO-LOGIC BANKER | Bio-Logic Systems Corp. | 1987-10-06 |
| K870381 | DD-VCR-64 | Grass-Telefactor Product Group | 1987-03-25 |
| K860914 | ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV | Bio-Feedback Systems, Inc. | 1986-06-06 |
| K843598 | BRAIN FUNCTION MAPPING OPTION FOR PATHF | Nicolet Biomedical Instruments | 1985-04-11 |
| K841497 | NEUROPACK 8 MEE 4108 | Nihon Kohden America, Inc. | 1984-06-07 |
| K841110 | NEUROTRAC | Interspec, Inc. | 1984-04-30 |
| K833298 | AUDIT V AX 135 | Axonics, Inc. | 1983-12-01 |
| K830191 | NEURO DIAGNOSTICS MODEL FCR | Neurodiagnostics, Inc. | 1983-02-18 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases