Atlas FDA

GWK

23 FDA 510(k) clearances · Product code

68 daysmedian time to decision
197 days90th percentile
23clearances measured

FDA profile

Official device name
Conditioner, Signal, Physiological
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1845
Medical specialty
Neurology
Flags
Third-party review eligible
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RecordFirmDate
ACTICAL (K060919)Respironics, Inc.2006-09-22
VITALSENSE XHR (K061870)Respironics, Inc.2006-08-31
ACTIHEART (K052489)Respironics, Inc.2005-09-27
MINI-LOGGER SERIES 2000 (K991045)Mini-Mitter Co., Inc.1999-09-21
NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 (K905594)Nihon Kohden America, Inc.1991-06-28
VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (K904328)Telediagnostic Systems, Inc.1991-06-18
ASC-954 INTEGRATOR AMPLIFIER (K896164)Astro-Med, Inc.1990-01-22
NICOLET BRAINLAB SYSTEM (K882599)Nicolet Instrument Corp.1988-10-19
BIO-LOGIC BANKER (K872290)Bio-Logic Systems Corp.1987-10-06
DD-VCR-64 (K870381)Grass-Telefactor Product Group1987-03-25
ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV (K860914)Bio-Feedback Systems, Inc.1986-06-06
BRAIN FUNCTION MAPPING OPTION FOR PATHF (K843598)Nicolet Biomedical Instruments1985-04-11
NEUROPACK 8 MEE 4108 (K841497)Nihon Kohden America, Inc.1984-06-07
NEUROTRAC (K841110)Interspec, Inc.1984-04-30
AUDIT V AX 135 (K833298)Axonics, Inc.1983-12-01
NEURO DIAGNOSTICS MODEL FCR (K830191)Neurodiagnostics, Inc.1983-02-18
EVOKED RESPONSE STIMULATORS (K803226)Bio-Logic Systems Corp.1981-02-05
PATHFINDER ELECTRODIAGNOSTIC SYSTEM (K801604)Nicolet Biomedical Instruments1980-08-04
NDI-IKE EMG (K801670)Neurodiagnostics, Inc.1980-08-04
SIGNAL AVERAGER MODEL 4202 (K781290)Princeton Applied Research Corp.1978-09-15
AUDIO MONITOR-MODEL 8309 (K780538)Life-Tech Instruments, Inc.1978-04-19
EVOKED RESPONSE SYS., MODEL 10 (K771742)Grass Instrument Co.1977-11-22
FIBERSCOPIC SCOPE RECORDER SYSTEM (K770782)Elmed, Inc.1977-05-06

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Every clearance here is in the API, with alerts when new ones post.