510(k) Report

Devices descending from K883038

127 later devices reach P/N 9320 Low Flow Air/Oxygen Microblender through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+9K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+9K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+9K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+9K103211Avea VentilatorCare Fusion20115Class I
+10K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+10K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+10K210384Carescape R860Datex-Ohmeda, Inc.20210—
+10K193228Hamilton-G5Hamilton Medical AG20201—
+10K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+10K170872Aisys CS2Datex-Ohmeda, Inc.201704
+10K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+10K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+10K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+10K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+11K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+11K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+11K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+11K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+11K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+11K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+12K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+12K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+12K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+12K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+13K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—