510(k) Report

Devices descending from K021174

12 later devices reach Ecom Endotrachial Cardiac Output Monitor through their predicates, nearest generation first.

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