510(k) Report

Devices descending from K001564

23 later devices reach Scan LT40 (40 Channels) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093223Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited20101—
+1K023536NuampsNeuroscan200320—
+2K230073OktiCompumedics Limited20230—
+2K060803G.UsbampG.Tec Medical Engineering GmbH200619—
+3K123255g.HIampG.Tec Medical Engineering GmbH20124—
+3K103140Nicolet Wireless EegCarefusion 209, Inc.201171
+3K090957Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC2009132
+4K202174Digital NeuroPort Biopotential Signal Processing SystemBlackrock Microsystems20210—
+4K191432cortiQ PROG.Tec Medical Engineering GmbH20200—
+4K171397Sienna Ultimate Wireless AmplifierEms Handels Gesellschaft M.B.H.20170—
+4K171669g.Nautilus PROG.Tec Medical Engineering GmbH20172—
+4K170441ElectroTekMobilemedtek201712
+4K162681Enobio Wireless EEGNeuroelectrics Barcelona S.L.U.20171—
+4K151600R-40 EEG AmplifierLifelines, Ltd.20151—
+4K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC20133—
+5K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.20260—
+5K212788Seer HomeSeer Medical Pty, Ltd.202201
+5K203331Quick-20mCgx, LLC20211—
+5K172271Trackit T4 EEG AmplifierLifelines, Ltd.20180—
+5K171384Micromed BRAIN QUICK systemMicromed S.P.A.201801
+5K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd.20151—
+6K232210X-trodes System MX-Trodes20240—
+6K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd.20220—