Product code GWK— Neurology

FDA has cleared 23 devices under product code GWK between 1977 and 2006, filed by 17 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20062 clearances
• 20051 clearance
• 19991 clearance
• 19912 clearances
• 19901 clearance
• 19881 clearance
• 19872 clearances
• 19861 clearance
• 19851 clearance
• 19842 clearances
• 19832 clearances
• 19811 clearance
• 19802 clearances
• 19782 clearances
• 19772 clearances

• Respironics, Inc.3 clearances
• Nihon Kohden America, Inc.2 clearances
• Nicolet Biomedical Instruments2 clearances
• Neurodiagnostics, Inc.2 clearances
• Bio-Logic Systems Corp.2 clearances
• Telediagnostic Systems, Inc.1 clearance
• Princeton Applied Research Corp.1 clearance
• Nicolet Instrument Corp.1 clearance
• Mini-Mitter Co., Inc.1 clearance
• Life-Tech Instruments, Inc.1 clearance

• K060919 — ACTICALRespironics, Inc.·2006-09-22
• K061870 — VITALSENSE XHRRespironics, Inc.·2006-08-31
• K052489 — ACTIHEARTRespironics, Inc.·2005-09-27
• K991045 — MINI-LOGGER SERIES 2000Mini-Mitter Co., Inc.·1999-09-21
• K905594 — NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300Nihon Kohden America, Inc.·1991-06-28
• K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMTelediagnostic Systems, Inc.·1991-06-18
• K896164 — ASC-954 INTEGRATOR AMPLIFIERAstro-Med, Inc.·1990-01-22
• K882599 — NICOLET BRAINLAB SYSTEMNicolet Instrument Corp.·1988-10-19
• K872290 — BIO-LOGIC BANKERBio-Logic Systems Corp.·1987-10-06
• K870381 — DD-VCR-64Grass-Telefactor Product Group·1987-03-25
• K860914 — ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONVBio-Feedback Systems, Inc.·1986-06-06
• K843598 — BRAIN FUNCTION MAPPING OPTION FOR PATHFNicolet Biomedical Instruments·1985-04-11
• K841497 — NEUROPACK 8 MEE 4108Nihon Kohden America, Inc.·1984-06-07
• K841110 — NEUROTRACInterspec, Inc.·1984-04-30
• K833298 — AUDIT V AX 135Axonics, Inc.·1983-12-01
• K830191 — NEURO DIAGNOSTICS MODEL FCRNeurodiagnostics, Inc.·1983-02-18
• K803226 — EVOKED RESPONSE STIMULATORSBio-Logic Systems Corp.·1981-02-05
• K801604 — PATHFINDER ELECTRODIAGNOSTIC SYSTEMNicolet Biomedical Instruments·1980-08-04
• K801670 — NDI-IKE EMGNeurodiagnostics, Inc.·1980-08-04
• K781290 — SIGNAL AVERAGER MODEL 4202Princeton Applied Research Corp.·1978-09-15
• K780538 — AUDIO MONITOR-MODEL 8309Life-Tech Instruments, Inc.·1978-04-19
• K771742 — EVOKED RESPONSE SYS., MODEL 10Grass Instrument Co.·1977-11-22
• K770782 — FIBERSCOPIC SCOPE RECORDER SYSTEMElmed, Inc.·1977-05-06