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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K131383

X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE · Advanced Brain Monitoring, Inc. · decided 2013-11-27 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
X-Series02-4321ADVANCED BRAIN MONITORING, INC.GWQ OMC00850015266409
X-SeriesXS10-4001ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007604
X-SeriesXS30-1001ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007529
X-Series, X831-1003, 31-1004ADVANCED BRAIN MONITORING, INC.GWQ OLV OMC00851113007833
X-SeriesXS30-4251.10ADVANCED BRAIN MONITORING, INC.GWQ OMC00850015266751
X-SeriesES31-1001, ES31-1003ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007918
X-SeriesXS10-1001, XS10-1003ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007703
X-SeriesXS30-4001ADVANCED BRAIN MONITORING, INC.GWQ OMC00850015266799
X-SeriesUN03-4009ADVANCED BRAIN MONITORING, INC.GWQ OMC00850015266904
X-SeriesES31-1001, ES31-1003ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007475
X-SeriesXS30-4302ADVANCED BRAIN MONITORING, INC.GWQ OMC00850015266935
X-Series, X8UN03-4008(ITA)ADVANCED BRAIN MONITORING, INC.GWQ OLV OMC00850015266584
X-SeriesXS30-4250.5ADVANCED BRAIN MONITORING, INC.GWQ OMC00850015266720
X-SeriesXS30-4250ADVANCED BRAIN MONITORING, INC.GWQ OMC00850015266713
X-SeriesXS30-4220ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007796
X-SeriesXS10-4220ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007635
X-SeriesXS02-4351ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007451
X-Series03-5105ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007420
X-SeriesXS24-4202ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007680
X-Series30-4210ADVANCED BRAIN MONITORING, INC.GWQ OMC00850015266416
X-SeriesXS30-1004, XS30-1005ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007857
X-Series, X8UN03-4008(POL)ADVANCED BRAIN MONITORING, INC.GWQ OLV OMC00850015266805
X-Series30-4211ADVANCED BRAIN MONITORING, INC.GWQ OMC00850015266287
X-SeriesXS24-4201ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007673
X-Series02-4321ADVANCED BRAIN MONITORING, INC.GWQ OMC00851113007444