Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1845](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1845) → GWK — Conditioner, Signal, Physiological # GWK · Conditioner, Signal, Physiological _Neurology · 21 CFR 882.1845 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK ## Overview - **Product Code:** GWK - **Device Name:** Conditioner, Signal, Physiological - **Regulation:** [21 CFR 882.1845](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1845) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 23) Showing 20 most recent of 23 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K060919](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K060919.md) | ACTICAL | Respironics, Inc. | Sep 22, 2006 | SESE | | [K061870](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K061870.md) | VITALSENSE XHR | Respironics, Inc. | Aug 31, 2006 | SESE | | [K052489](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K052489.md) | ACTIHEART | Respironics, Inc. | Sep 27, 2005 | SESE | | [K991045](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K991045.md) | MINI-LOGGER SERIES 2000 | Mini-Mitter Co., Inc. | Sep 21, 1999 | SESE | | [K905594](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K905594.md) | NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 | Nihon Kohden America, Inc. | Jun 28, 1991 | SESE | | [K904328](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K904328.md) | VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM | Telediagnostic Systems, Inc. | Jun 18, 1991 | SESE | | [K896164](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K896164.md) | ASC-954 INTEGRATOR AMPLIFIER | Astro-Med, Inc. | Jan 22, 1990 | SESE | | [K882599](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K882599.md) | NICOLET BRAINLAB SYSTEM | Nicolet Instrument Corp. | Oct 19, 1988 | SESE | | [K872290](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K872290.md) | BIO-LOGIC BANKER | Bio-Logic Systems Corp. | Oct 6, 1987 | SESE | | [K870381](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K870381.md) | DD-VCR-64 | Grass-Telefactor Product Group | Mar 25, 1987 | SESE | | [K860914](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K860914.md) | ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV | Bio-Feedback Systems, Inc. | Jun 6, 1986 | SESE | | [K843598](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K843598.md) | BRAIN FUNCTION MAPPING OPTION FOR PATHF | Nicolet Biomedical Instruments | Apr 11, 1985 | SESE | | [K841497](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K841497.md) | NEUROPACK 8 MEE 4108 | Nihon Kohden America, Inc. | Jun 7, 1984 | SESE | | [K841110](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K841110.md) | NEUROTRAC | Interspec, Inc. | Apr 30, 1984 | SESE | | [K833298](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K833298.md) | AUDIT V AX 135 | Axonics, Inc. | Dec 1, 1983 | SESE | | [K830191](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K830191.md) | NEURO DIAGNOSTICS MODEL FCR | Neurodiagnostics, Inc. | Feb 18, 1983 | SESE | | [K803226](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K803226.md) | EVOKED RESPONSE STIMULATORS | Bio-Logic Systems Corp. | Feb 5, 1981 | SESE | | [K801670](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K801670.md) | NDI-IKE EMG | Neurodiagnostics, Inc. | Aug 4, 1980 | SESE | | [K801604](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K801604.md) | PATHFINDER ELECTRODIAGNOSTIC SYSTEM | Nicolet Biomedical Instruments | Aug 4, 1980 | SESE | | [K781290](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK/K781290.md) | SIGNAL AVERAGER MODEL 4202 | Princeton Applied Research Corp. | Sep 15, 1978 | SESE | ## Top Applicants - Respironics, Inc. — 3 clearances - Bio-Logic Systems Corp. — 2 clearances - Neurodiagnostics, Inc. — 2 clearances - Nicolet Biomedical Instruments — 2 clearances - Nihon Kohden America, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com