Amplifier, Physiological Signal
Neurology · 21 CFR 882.1835
Recent MDR events
5 adverse event reports on file
- NIHON KOHDEN TELEMETRY PACK BATTERYJun 12, 2018MalfunctionNihon Kohden America Inc.MW5077817
- SANDMAN DIGITAL 20 (SD20)May 16, 2008OtherEb Neuro Spa9680138-2008-00001_2
- Unnamed deviceMay 16, 2008Other9617286-2008-00001
- MEM-4104KApr 29, 2002OtherNihon Kohden2080783-2002-00001
- Unnamed deviceApr 29, 2002Malfunction9611252-2002-00001
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Blackrock Microsystems, LLCTerminatedSep 8, 2016
Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747.
Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts.
Z-2763-2016 · View FDA record ↗ - Blackrock Microsystems, LLCTerminatedSep 8, 2016
Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons.
Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts.
Z-2764-2016 · View FDA record ↗ - Natus Neurology IncorporatedTerminatedMar 13, 2013
Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier.
Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn.
Z-0946-2013 · View FDA record ↗ - I2s Micro Implantable Systems LlcTerminatedMay 20, 2010
Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics Neurotechnology Systems, Inc., Salt Lake
Component of cranial array may not allow sufficient tightening to maintain inserter position.
Z-1619-2010 · View FDA record ↗
Registered firms
44 firms currently registered for this product code
Ems Handels Gesellschaft M.b.h.
Korneuburg Niederosterreich, AT
Remware
Tampa, FL, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Natus Neurology Incorporated
Middleton, WI, US
G.tec Medical Engineering Gmbh
SCHIEDLBERG Oberosterreich, AT
Hi Tech Electronic Manufacturing Corporation
Oceanside, CA, US
Neurotronics, Llc
Alachua, FL, US
Lifelines Ltd.
WOKING Surrey, GB
Natus Manufacturing Limited
GORT, Co. Galway, IE
Cadwell Industries, Inc.
KENNEWICK, WA, US
Intelligent Hearing Systems Corp.
MIAMI, FL, US
Cgx, Llc
San Diego, CA, US
Dormotech Medical Ltd.
Afula Northern, IL
Lifelines Neuro Company
Louisville, KY, US
Brainmatterz, Inc
McKinney, TX, US
Blackrock Microsystems
Salt Lake City, UT, US
Neuroelectrics Barcelona S.l.u.
Barcelona Catalonia, ES
Eb Neuro S.p.a.
Arbizzano di Valpolicella Verona, IT
Hipposcreen Neurotech Corp.
Neihu Dist. Taipei, TW
G.tec Medical Engineering Gmbh
Graz Steiermark, AT
510(k) clearances
53 clearances for this product code
- Quantalx NeroscienceMar 12, 2025
K243746 · Delphi Amplifier
- Eb Neuro S.P.A.Dec 12, 2024
K242832 · NExT Station; NExT Station Advanced
- Eb Neuro S.P.A.Sep 4, 2024
K242305 · BE Plus PRO, Neurotravel LIGHT
- Somnomed Technologies Inc., Doing Business AS RemwareSep 4, 2024
K240646 · DreamClear
- X-TrodesFeb 4, 2024
K232210 · X-trodes System M
- Dormotech Medical, Ltd.Oct 11, 2023
K230148 · Vlab
- Brainmatterz, LLCJun 1, 2023
K223676 · SomniCheck
- Neurotronics, Inc.Jul 15, 2022
K220631 · NomadAir PMU810