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BTL — Ventilator, Emergency, Powered (Resuscitator) Class II

FDA Device Classification

Classification Details

Product Code
BTL
Device Class
Class II
Regulation Number
868.5925
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242769draegerwerk ag and co kgaaVentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)April 4, 2025
K221634magnamed tecnologia medica s/aOxymag - Transport and Emergency VentilatorMay 24, 2023
K202219vortran medical technology 1VORTRAN GO2VENT with PEEP ValveFebruary 11, 2021
K193191weinmann emergency medical technology gmbh + co. kgMEDUMAT Easy CPR, MEDUMAT Easy CPR with bagNovember 20, 2020
K182956international biomedicalPuffin Lite Infant Resuscitation SystemJanuary 18, 2019
K173373ventlabSafeT T-Piece ResuscitatorNovember 16, 2018
K161420thornhill researchMOVES SLCJune 6, 2017
K162968vortran medical technology 1VORTRAN GO2VENTApril 10, 2017
K141595o-two medical technologiesO-TWO E700,O-TWO E600,O-TWO E500March 16, 2015
K142096mercury medicalT-PIECE RESUSCITATOROctober 17, 2014
K140049thornhill researchMOVES SLCMay 29, 2014
K140707international biomedicalLIFEBORNE INFANT RESUSCITATORMay 28, 2014
K131098allied healthcare productsEMERGENCY PORTABLE VENTILATORApril 9, 2014
K132021allied healthcare productsAHP 300, EMERGENCY PORTABLE VENTILATORApril 2, 2014
K132759dolphys medicalVENTRAINMarch 26, 2014
K131877automedxSAVE II, SAVE II BASICMarch 21, 2014
K123957smiths medical internationalPNEUPAC PARAPAC PLUSSeptember 16, 2013
K112783vbm medizintechnikMANUJET IIIDecember 22, 2011
K102542atom medical corporationRESUSCI FLOW; RESUSCI FLOW 104April 6, 2011
K093862o-two medical technologiesCAREVENT HANDHELD CPAP SYSTEMMay 6, 2010