510(k) Report

Devices descending from K040113

16 later devices reach Sandman SD20 Amplifier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223676SomniCheckBrainmatterz, LLC20230—
+1K103140Nicolet Wireless EegCarefusion 209, Inc.201171
+1K090957Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC2009132
+1K050919Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…Analogic Corp.20050—
+2K202174Digital NeuroPort Biopotential Signal Processing SystemBlackrock Microsystems20210—
+2K171397Sienna Ultimate Wireless AmplifierEms Handels Gesellschaft M.B.H.20170—
+2K170441ElectroTekMobilemedtek201712
+2K162681Enobio Wireless EEGNeuroelectrics Barcelona S.L.U.20171—
+2K151600R-40 EEG AmplifierLifelines, Ltd.20151—
+2K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC20133—
+3K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.20260—
+3K212788Seer HomeSeer Medical Pty, Ltd.202201
+3K172271Trackit T4 EEG AmplifierLifelines, Ltd.20180—
+3K171384Micromed BRAIN QUICK systemMicromed S.P.A.201801
+3K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd.20151—
+4K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd.20220—