Neurofile Data Storage/Accesories to the EEG-4300
FDA 510(k) K905594 · Nihon Kohden America, Inc.
510(k) numberK905594
Submission
- Device name
- Neurofile Data Storage/Accesories to the EEG-4300
- Applicant
- Nihon Kohden America, Inc.
Irvine, CA, US - Received
- December 13, 1990
- Decision date
- June 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GWK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060919 | ActicalGWK · Traditional | Respironics, Inc. | 09/22/2006SE |
| K061870 | Vitalsense XHRGWK · Special | Respironics, Inc. | 08/31/2006SE |
| K052489 | ActiheartGWK · Traditional | Respironics, Inc. | 09/27/2005SE |
| K991045 | Mini-Logger Series 2000GWK · Traditional | Mini-Mitter Co., Inc. | 09/21/1999SE |
| K904328 | Vista Polysomnography Computer SystemGWK · Traditional | Telediagnostic Systems, Inc. | 06/18/1991SE |
| K896164 | ASC-954 Integrator AmplifierGWK · Traditional | Astro-Med, Inc. | 01/22/1990SE |
| K882599 | Nicolet Brainlab SystemGWK · Traditional | Nicolet Instrument Corp. | 10/19/1988SE |
| K872290 | Bio-Logic BankerGWK · Traditional | Bio-Logic Systems Corp. | 10/06/1987SE |
| K870381 | DD-VCR-64GWK · Traditional | Grass-Telefactor Product Group | 03/25/1987SE |
| K860914 | Isolated Solid-State Relay Multiplexer & F/F ConvGWK · Traditional | Bio-Feedback Systems, Inc. | 06/06/1986SE |
More from Bio-Feedback Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K113117 | Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction BoxGWQ · Special | 03/22/2012SE |
| K120485 | Nihon Kohden QP-160 Ak Trend Program with the Addition of Dsa Asymmetry Trend and FFT POMA · Special | 03/16/2012SE |
| K092573 | Nihon Kohden QP-160AK EEG Trend ProgramOMA · Traditional | 07/09/2010SE |
| K083456 | Nihon Kohden CO2 Sensor Kit, Model TG-970PCCK · Special | 03/02/2009SE |
| K083271 | BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series…MHX · Special | 12/24/2008SE |
| K082785 | Nihon Kohden Bedside Monitor, BSM 9100A SeriesMHX · Special | 11/26/2008SE |
| K071969 | SEN-4100 Electric StimulatorGWF · Traditional | 10/06/2008SE |
| K080546 | Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200AOLT · Special | 08/29/2008SE |
| K073550 | Prefense EDNS-9000 Series Nurse Central StationMHX · Special | 03/28/2008SE |
| K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesMHX · Special | 02/26/2008SE |
Questions and answers
When was Neurofile Data Storage/Accesories to the EEG-4300 cleared by the FDA?
Neurofile Data Storage/Accesories to the EEG-4300 (K905594) received a 510(k) decision of Substantially Equivalent on June 28, 1991, 197 days after the submission was received.
What is the product code of K905594?
The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.