Product code GWK
- Device name
- Conditioner, Signal, Physiological
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1845
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K905594 | NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 | Nihon Kohden America, Inc. | 1991-06-28 |
| 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 |
| K803226 | EVOKED RESPONSE STIMULATORS | Bio-Logic Systems Corp. | 1981-02-05 |
| K801604 | PATHFINDER ELECTRODIAGNOSTIC SYSTEM | Nicolet Biomedical Instruments | 1980-08-04 |
| K801670 | NDI-IKE EMG | Neurodiagnostics, Inc. | 1980-08-04 |
| K781290 | SIGNAL AVERAGER MODEL 4202 | Princeton Applied Research Corp. | 1978-09-15 |
| K780538 | AUDIO MONITOR-MODEL 8309 | Life-Tech Instruments, Inc. | 1978-04-19 |
| K771742 | EVOKED RESPONSE SYS., MODEL 10 | Grass Instrument Co. | 1977-11-22 |
| K770782 | FIBERSCOPIC SCOPE RECORDER SYSTEM | Elmed, Inc. | 1977-05-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00814901021541 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2025-02-14 |
| 00814901021527 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2023-12-04 |
| 00814901021534 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2023-12-04 |
| 00814901021473 | NeuroPlex E128 | BLACKROCK MICROSYSTEMS, LLC | 2023-05-18 |
| 00814901021480 | NeuroPlex E128 Sterile | BLACKROCK MICROSYSTEMS, LLC | 2023-05-18 |
| 00814901021435 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2022-09-20 |
| 00814901021442 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2022-09-20 |
| 00814901021411 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2021-11-24 |
| 00814901021350 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2021-07-01 |
| 00814901021343 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2021-07-01 |
| 00814901021367 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2021-07-01 |
| 00814901021404 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2021-07-01 |
| 00814901021374 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2021-07-01 |
| 00814901021381 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2021-07-01 |
| 00814901021398 | Digital NeuroPort Biopotential Signal Processing System | BLACKROCK MICROSYSTEMS, LLC | 2021-07-01 |
| B329AH556 | Actiheart | CAMNTECH LIMITED | 2019-08-29 |
| B329AHBT56 | Actiheart | CAMNTECH LIMITED | 2019-08-29 |
| 00850154007079 | MORPHEUS | BLACKROCK NEUROMED, LLC | 2016-12-07 |
| 00850154007086 | CERVELLO SOFTWARE | BLACKROCK NEUROMED, LLC | 2016-12-06 |
| 00850154007055 | JB CERVELLO 64 | BLACKROCK NEUROMED, LLC | 2016-12-06 |
| 00850154007048 | JB CERVELLO 32 | BLACKROCK NEUROMED, LLC | 2016-12-06 |
| 00850154007031 | CERVELLO 64 W | BLACKROCK NEUROMED, LLC | 2016-12-06 |
| 00850154007024 | CERVELLO 32 W | BLACKROCK NEUROMED, LLC | 2016-12-06 |
| 00850154007017 | CERVELLO 64 | BLACKROCK NEUROMED, LLC | 2016-12-05 |
| B329AH420 | Actiheart | CAMNTECH LIMITED | 2016-09-24 |
| 00606959021006 | Actical | Respironics, Inc. | 2016-09-19 |
| 00850154007000 | CERVELLO 32 | BLACKROCK NEUROMED, LLC | 2016-07-15 |