510(k) Report

Devices descending from K061090

36 later devices reach Galileo Gold Asv through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080181Modification to Galileo GoldHamilton Medical AG200821—
+1K070513Hamilton-G5Hamilton Medical AG2007261
+1K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+1K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+2K103803Hamilton-G5Hamilton Medical AG201114Class I
+2K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+2K102775Hamilton-C2Hamilton Medical AG201114—
+2K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+2K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+3K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+3K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+3K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+3K131774Hamilton-G5Hamilton Medical AG201310Class I
+3K121225Hamilton-C2Hamilton Medical AG20128Class I
+3K112006Hamilton-TC1Hamilton Medical AG201213—
+3K103211Avea VentilatorCare Fusion20115Class I
+3K090468Hamilton-C2Hamilton Medical AG20090—
+4K210384Carescape R860Datex-Ohmeda, Inc.20210—
+4K180295Hamilton-G5Hamiton Medical AG20192—
+4K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+4K161450Hamilton-C3Hamilton Medical AG201732
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+4K123637Hamilton-C3Hamilton Medical AG20124—
+4K120574Hamilton-C1Hamilton Medical AG20123—
+4K120670Hamilton-T1Hamilton Medical AG201211Class I
+5K233486731 Series VentilatorZOLL Medical Corporation20240—
+5K201306Hamilton-C3Hamilton Medical AG20210Class I
+5K201658Hamilton-C6Hamilton Medical AG20201Class I
+5K193228Hamilton-G5Hamilton Medical AG20201—
+5K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+5K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I
+6K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+6K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+6K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I