510(k) Report

Devices descending from K963183

13 later devices reach Bioz System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical200312—
+2K032491Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc.200311—
+3K131765Ecom Endotracheal Cardiac Output Monitor SystemConmed Corporation20131—
+3K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc.20108—
+4K172196ECOM™ Cardiac Output Monitoring SystemEcom Medical, Inc.20170—
+4K133530Nuvasive Emg Endotracheal TubeNu Vasive, Incorporated20140—
+4K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc.20121Class I
+4K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc.2011410
+5K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube…Medtronic Xomed, Inc.20260—
+5K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube…Inomed Medizintechnik GmbH20250—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K130806Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc.20130—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302