FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K211949 |
AirStrip Technologies, Inc. |
AirStrip ONE Web Client with Alarm Communication Management (ACM) |
12/09/2021 |
K160862 |
AirStrip Technologies, Inc. |
AirStrip RPM |
09/19/2016 |
K121712 |
AIRSTRIP TECHNOLOGIES, INC. |
AIRSTRIP RPM FOR LIFENET CONSULT |
11/20/2012 |
K210160 |
AlertWatch, Inc. |
AlertWatch:AC |
09/10/2021 |
K112047 |
AMCOM SOFTWARE,INC. |
AMCOM COMMTECH MESSENGER |
09/13/2011 |
K111215 |
ASCOM (SWEDEN) AB |
ASCOM MOBILE MONITORING GATEWAY (MMG) |
07/05/2011 |
K103634 |
ASCOM (US), INC. |
ASCOM CLINICALCONNEX CARDIOMAX |
02/23/2011 |
K180566 |
Ascom Sweden AB |
Unite Connect for Clinical Systems |
04/03/2018 |
K180430 |
ASCOM UMS srl unipersonale |
Digistat Smart Central |
11/23/2018 |
K173203 |
Athena GTX |
Athena GTX Device Management Suite (ADMS) Software |
03/14/2018 |
K213863 |
Biofourmis Singapore Pte. Ltd |
Everion+ System |
02/23/2023 |
K193421 |
BoxView, LLC |
Smart Alarm Interface |
10/30/2020 |
K061428 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
PMP4 APPLICATION |
10/16/2006 |
K061932 |
CARDIOPULMONARY CORP. |
BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE |
09/14/2006 |
K020018 |
CARDIOPULMONARY CORP. |
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE |
02/21/2002 |
K051283 |
CARDIOPULMONARY CORP. |
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE |
06/23/2005 |
K151672 |
CERNER CORPORATION |
Cerner CareAware Event Management |
12/21/2015 |
K112650 |
CONNEXALL USA, INC. |
CONNEXALL SUITE OF SOFTWARE PRODUCTS |
02/01/2012 |
K193043 |
Critical Alert |
Critical Alert CommonPath Enterprise |
05/11/2020 |
K982342 |
CRITIKON COMPANY,LLC |
DINAMAP MPS SELECT PORTABLE MONITOR |
08/14/1998 |
K210133 |
Current Health |
Current Health Monitoring System Gen 2 (G2) |
09/03/2021 |
K231506 |
Current Health Ltd |
Current Health System |
08/24/2023 |
K190073 |
Current Health Ltd |
Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub |
03/27/2019 |
K222550 |
Current Health Ltd. |
Current Health System |
11/01/2022 |
K191272 |
Current Health Ltd. |
Wearable Device, Wearable Package |
07/12/2019 |
K992848 |
DATA CRITICAL CORP. |
ALARMVIEW SYSTEM |
11/19/1999 |
K010912 |
DATA CRITICAL CORP. |
ALARMVIEW WIRELESS DATA NETWORK SYSTEM |
04/05/2001 |
K973527 |
DATA CRITICAL CORP. |
CARDIO-PAGER SYSTEM |
03/31/1998 |
K003998 |
DATA CRITICAL CORP. |
FLEXVIEW CLINICAL MONITORING SYSTEM |
03/07/2001 |
K012005 |
DATA CRITICAL CORP. |
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM |
07/24/2001 |
K013156 |
DATA CRITICAL CORP. |
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM |
10/19/2001 |
K011999 |
DATA CRITICAL CORP. |
MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM |
07/24/2001 |
K990378 |
DATA CRITICAL CORP. |
STATVIEW SYSTEM |
09/20/1999 |
K962473 |
DATA CRITICAL CORPORATION |
(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH |
11/06/1997 |
K974101 |
DATEX-ENGSTROM, INC. |
DATEX-ENGSTROM NETWORK |
02/06/1998 |
K033281 |
DATEX-OHMEDA |
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE |
11/26/2003 |
K033078 |
DATEX-OHMEDA |
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE |
10/29/2003 |
K012531 |
DATEX-OHMEDA |
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX |
11/02/2001 |
K013246 |
DATEX-OHMEDA |
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 |
12/11/2001 |
K022507 |
DATEX-OHMEDA |
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02 |
08/23/2002 |
K013387 |
DATEX-OHMEDA |
DATEX-OHMEDA S/5 WEB VIEWER |
01/08/2002 |
K023497 |
DATEX-OHMEDA |
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE |
11/04/2002 |
K042771 |
DATEX-OHMEDA |
GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 |
10/15/2004 |
K000647 |
DATEX-OHMEDA, INC. |
DATEX-OHMEDA NETWORK AND CENTRAL |
07/13/2000 |
K141756 |
Draeger Medical Systems, Inc. |
INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION |
12/12/2014 |
K203579 |
Draeger Medical Systems, Inc. |
Infinity Gateway Suite |
06/07/2022 |
K040945 |
Draeger Medical Systems, Inc. |
MODIFICATION TO INFINITY EXPLORER |
05/12/2004 |
K060254 |
Draeger Medical Systems, Inc. |
MODIFICATION TO INFINITY EXPLORER |
04/04/2006 |
K151006 |
EARLYSENSE LTD. |
EarlySense Central Display Station (CDS) |
08/31/2015 |
K121885 |
EARLYSENSE LTD. |
EARLYSENSE CENTRAL DISPLAY SYSTEM |
09/10/2012 |
K100376 |
EARLYSENSE LTD. |
EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 |
08/06/2010 |
K110521 |
EARLYSENSE LTD. |
EVERON CENTRAL DISPLAY STATION (CDS) |
04/19/2011 |
K130339 |
EXTENSION , INC |
CLINICAL ALERT NOTIFICATION |
07/11/2013 |
K052972 |
GE HEALTHCARE |
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 |
12/29/2005 |
K051634 |
GE HEALTHCARE |
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION |
07/19/2005 |
K070421 |
GE HEALTHCARE |
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 |
03/13/2007 |
K052975 |
GE HEALTHCARE |
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE |
01/20/2006 |
K061994 |
GE HEALTHCARE |
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE |
08/11/2006 |
K032346 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
UNITY NETWORK IS PATIENT VIEWER |
08/05/2003 |
K032582 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
UNITY NETWORK PATIENT DATA SERVER |
09/17/2003 |
K994430 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM |
03/28/2000 |
K020524 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
PATIENTNET MONITORING SYSTEM |
03/20/2002 |
K020661 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
UNITY IS PATIENT VIEWER |
05/24/2002 |
K974567 |
HEWLETT-PACKARD CO. |
HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER |
01/20/1998 |
K130707 |
ISIRONA, LLC |
ISIRONA MAGELLAN |
11/20/2013 |
K971569 |
JOHNSON & JOHNSON MEDICAL, INC. |
DINAMAP MPS PORTABLE MONITOR |
09/19/1997 |
K971868 |
MARQUETTE ELECTRONICS, INC. |
IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM |
11/13/1997 |
K971683 |
MARQUETTE ELECTRONICS, INC. |
WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET |
10/22/1997 |
K071047 |
MASIMO CORPORATION |
MASIMO PATIENT SAFETY NET |
06/08/2007 |
K052854 |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
LIFENET EXCHANGE SYSTEM |
01/20/2006 |
K112282 |
MVISUM, INC. |
M VISUM ALERT ALARM MANAGEMENT SYSTEM |
11/04/2011 |
K223567 |
Nihon Kohden Corporation |
CNS-2101 Central Monitor |
07/31/2023 |
K973318 |
ORTIVUS US, INC. |
MOBIMED SYSTEM, (PEGASUS AND POLARIS) |
02/19/1998 |
K142935 |
PHILIPS MEDICAL SYSTEMS |
CareEvent |
01/15/2015 |
K161164 |
PHILIPS MEDICAL SYSTEMS |
CareEvent inclusive of the CareEvent Mobile Application accessory |
06/24/2016 |
K102974 |
PHILIPS MEDICAL SYSTEMS |
INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 |
01/04/2011 |
K143057 |
PHILIPS MEDICAL SYSTEMS |
M3290B Philips IntelliVue Information Center iX |
12/03/2014 |
K091176 |
PHILIPS MEDICAL SYSTEMS |
PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441 |
11/13/2009 |
K071391 |
PHILIPS MEDICAL SYSTEMS, INC. |
PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 |
09/07/2007 |
K182637 |
Philips Medizin Systeme Boeblingen GmbH |
Philips IntelliVue XDS Software |
04/26/2019 |
K042845 |
PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH |
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS |
11/12/2004 |
K093925 |
PHYSIO-CONTROL, INC. |
LIFENET SYSTEM |
01/12/2010 |
K102757 |
PHYSIO-CONTROL, INC. |
LIFENET SYSTEM |
11/05/2010 |
K162607 |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
BeneVision Central Monitoring System |
04/20/2017 |
K220058 |
Shenzhen Mindray Bio-Medical Electronics Co., LTD |
BeneVision Central Monitoring System |
06/01/2022 |
K150632 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
Hypervisor IX Monitoring System |
07/06/2015 |
K080192 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) |
04/03/2008 |
K183238 |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
BeneVision Central Monitoring System |
03/13/2019 |
K193391 |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
BeneVision Central Monitoring System |
05/21/2020 |
K132036 |
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD |
HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016) |
07/01/2014 |
K030615 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
INFINITY EXPLORER |
03/21/2003 |
K182543 |
snap40 Ltd |
Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package |
11/14/2018 |
K062278 |
SPACELABS MEDICAL INC. |
SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 |
09/19/2006 |
K992749 |
SPACELABS MEDICAL, INC. |
ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841 |
01/14/2000 |
K192952 |
Spire, Inc. d/b/a Spire Health |
Spire Health Remote Patient Monitoring System |
06/05/2020 |
K202497 |
Taiwan Aulisa Medical Devices Technologies, Inc. |
Aulisa Multiple Patient Digital Vital Sign Monitoring System |
10/30/2020 |
K973640 |
TRINCORE SYSTEMS, INC. |
TS2000 MEDICAL DEVICE MONITOR |
03/12/1998 |
K140852 |
VECTRACOR, INC |
VECTRAPLEX CMS |
01/30/2015 |
K972880 |
VIDCO, INC. |
MDP2000 MEDICAL DATA PROCESSOR |
10/22/1997 |
K001972 |
VISICU, INC. |
ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK |
10/27/2000 |
K153156 |
VISICU, INC. |
eCareManager 4.0.1 |
09/30/2016 |
K171322 |
Visicu, Inc. |
eCareManager 4.1 |
08/03/2017 |
K211046 |
Visicu, Inc. |
eCareManager 4.5 |
06/03/2022 |
K012171 |
VISICU, INC. |
MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS |
07/24/2001 |
K070204 |
WELCH ALLYN PROTOCOL, INC. |
LINK TO ACUITY CLINICIAN NOTIFIER |
03/23/2007 |
K121865 |
ZOLL MEDICAL CORPORATION |
ZOLL RESCUENET 12-LEAD |
11/20/2012 |
K111296 |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
ZOLL RESCUENETLINK |
10/27/2011 |
K212622 |
Zyter, Inc. |
Zyter RPM |
02/11/2022 |