FDA 510(k) Applications Submitted by Draeger Medical Systems, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K113798 12/23/2011 INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET Draeger Medical Systems, Inc.
K133175 10/17/2013 DRAEGER JAUNDICE METER JM-105 DRAEGER MEDICAL SYSTEMS, INC.
K113206 11/01/2011 NANOBLUTM 500 Draeger Medical Systems, Inc.
K093788 12/09/2009 INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION Draeger Medical Systems, Inc.
K203088 10/13/2020 Infinity Acute Care System (IACS) Monitoring System Draeger Medical Systems, Inc.
K203579 12/07/2020 Infinity Gateway Suite Draeger Medical Systems, Inc.
K120642 03/02/2012 RESUSCITAIRE WITH AUTOBREATH Draeger Medical Systems, Inc.
K141565 06/12/2014 GLOBE-TROTTER GT5400 Draeger Medical Systems, Inc.
K172656 09/05/2017 BiliLux Draeger Medical Systems, Inc.
K073113 11/05/2007 INFINITY PICCO POD, MODEL MS16734 Draeger Medical Systems, Inc.
K102968 10/06/2010 INFINITY CNAP SMARTPOD Draeger Medical Systems, Inc.
K103625 12/10/2010 OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE Draeger Medical Systems, Inc.
K060039 01/06/2006 INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS Draeger Medical Systems, Inc.
K182977 10/26/2018 Isolette 8000 Plus Draeger Medical Systems, Inc.
K141756 06/30/2014 INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION Draeger Medical Systems, Inc.
K060223 01/30/2006 INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM Draeger Medical Systems, Inc.
K060254 02/01/2006 MODIFICATION TO INFINITY EXPLORER Draeger Medical Systems, Inc.
K053484 12/15/2005 INFINITY GAMMA / GAMMAXL, INFINITY VISTA Draeger Medical Systems, Inc.
K230278 02/01/2023 Babyroo TN300 Draeger Medical Systems, Inc.
K070566 02/28/2007 INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL Draeger Medical Systems, Inc.
K040188 01/28/2004 INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE Draeger Medical Systems, Inc.
K040945 04/12/2004 MODIFICATION TO INFINITY EXPLORER Draeger Medical Systems, Inc.
K050974 04/18/2005 DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS Draeger Medical Systems, Inc.
K041087 04/26/2004 INFINITY GAMMA Draeger Medical Systems, Inc.
K051628 06/20/2005 INFINITY MONITORS WITH SCIO MODIFICATIONS Draeger Medical Systems, Inc.
K051658 06/21/2005 INFINITY ALPHA Draeger Medical Systems, Inc.
K042003 07/26/2004 INFINITY TRIDENT NMT POD Draeger Medical Systems, Inc.
K032537 08/18/2003 DRAEGER MICRO2+ AND MASIMO MINISAT Draeger Medical Systems, Inc.
K042656 09/28/2004 INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 Draeger Medical Systems, Inc.
K033305 10/14/2003 INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM Draeger Medical Systems, Inc.
K042904 10/21/2004 INFINITY KAPPA XLT Draeger Medical Systems, Inc.
K033600 11/14/2003 INFINITY GAMMAXL Draeger Medical Systems, Inc.
K033694 11/24/2003 INFINITY MODULAR MONITORS VF4 MODIFICATIONS Draeger Medical Systems, Inc.
K033807 12/08/2003 INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER Draeger Medical Systems, Inc.
K043439 12/14/2004 INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL Draeger Medical Systems, Inc.
K033957 12/22/2003 INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL Draeger Medical Systems, Inc.
K043549 12/23/2004 INFINITY GATEWAY SUITE, VF4 Draeger Medical Systems, Inc.
K082888 09/30/2008 INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 Draeger Medical Systems, Inc.
K061329 05/12/2006 INFINITY MASIMO SET SP02 POD Draeger Medical Systems, Inc.
K200859 04/01/2020 Infinity M300 Draeger Medical Systems, Inc.
K151860 07/08/2015 Infinity CentralStation Wide Draeger Medical Systems, Inc.
K061379 05/17/2006 INFINITY TELESMART TELEMETRY SYSTEM Draeger Medical Systems, Inc.
K201764 06/29/2020 Infinity Acute Care System (IACS) Monitoring Solution Draeger Medical Systems, Inc.
K130711 03/15/2013 INFINITY CENTRALSTATION WITH INFINITY M300 Draeger Medical Systems, Inc.


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