510(k) Report

Devices descending from K013642

133 later devices reach AVEA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+6K153061Juno VPAP ST-AResmed, Ltd.20163—
+6K122438Hamilton-MR1Hamilton Medical AG201311
+6K123511S9 Vpap TXResmed, Ltd.20131—
+6K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+6K122324Vpap S-aResmed, Ltd.20120—
+6K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+6K103803Hamilton-G5Hamilton Medical AG201114Class I
+6K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+6K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+7K213169BPAP SystemBMC Medical Co., Ltd.20220—
+7K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+7K161492Juno VPAP ST-AResmed, Ltd.20171—
+7K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+7K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+7K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+7K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+7K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+7K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+7K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+7K121225Hamilton-C2Hamilton Medical AG20128Class I
+8K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+8K170872Aisys CS2Datex-Ohmeda, Inc.201704
+8K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+8K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+8K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+8K123637Hamilton-C3Hamilton Medical AG20124—
+9K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+9K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+10K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+10K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+10K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+11K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—