FDA 510(k) Applications for Medical Device Product Code "DRT"
(Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))

FDA 510(k) Number Applicant Device Name Decision Date
K002061 A & D ENGINEERING, INC. A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR 01/19/2001
K010587 ACTIVE CORP. ACTIVEECG 05/16/2001
K972789 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016 10/17/1997
K972787 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P 10/17/1997
K051038 CIRITICARE SYSTEMS, INC. 506 PATIENT MONITOR 08/12/2005
K012763 COBE CARDIOVASCULAR, INC. SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM 11/15/2001
K181165 Connected Sensing- A Division of Philips Medical Systems Philips wearable biosensor-G5 Solution 03/07/2019
K091050 CRITICARE SYSTEMS, INC. 506CN PATIENT MONITOR 05/27/2009
K022435 CRITICARE SYSTEMS, INC. 507EL VITAL SIGNS MONITOR 08/14/2002
K974178 DATASCOPE CORP. PASSPORT 5L-CE MODEL 0998-00-0131XXX 06/26/1998
K981378 DATEX-ENGSTROM, INC. DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 11/03/1998
K030656 ENVAN, LLC ENVAN HEART RATE MONITOR 04/08/2003
K121860 FLUKE BIOMEDICAL ESA615 01/25/2013
K121722 FLUKE BIOMEDICAL ESA620 ELECTRICAL SAFETY ANALYZER 10/11/2012
K103336 FLUKE BIOMEDICAL MPS450 MULTIPARAMETER SIMULATOR 04/13/2011
K110429 FLUKE BIOMEDICAL PROSIM 4, PROSIM 6, PROSIM 8 09/02/2011
K060307 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 12 RL ALGORITHM 08/04/2006
K033646 HEALTHFIRST CORP. TRIFIT 700 03/01/2005
K052446 HOANA MEDICAL, INC. LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM 02/02/2006
K100745 HOANA MEDICAL, INC. LIFEBED NETWORK PATIENT VIGILANCE SYSTEM 04/15/2010
K083534 HOANA MEDICAL, INC. LIFEBED NETWORK PATIENT VIGILANCE SYSTEM 04/13/2009
K082366 HOANA MEDICAL, INC. LIFEBED PATIENT VIGILANCE SYSTEM 09/26/2008
K092037 HOANA MEDICAL, INC. LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM 10/02/2009
K974581 INVIVO RESEARCH, INC. MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT 10/28/1998
K043354 INVIVO RESEARCH, INC. MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 01/10/2005
K151781 IVY BIOMEDICAL SYSTEMS INC. Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor 05/27/2016
K110987 IVY BIOMEDICAL SYSTEMS, INC. CARDIAC TRIGGER MONITOR 07/22/2011
K170828 Ivy Biomedical Systems, Inc. Cardiac Trigger Monitor 05/17/2017
K202138 Ivy Biomedical Systems, Inc. Cardiac Trigger Monitor 05/14/2021
K083854 IVY BIOMEDICAL SYSTEMS, INC. CARDIAC TRIGGER, MODEL: CTM300 02/13/2009
K023616 IVY BIOMEDICAL SYSTEMS, INC. PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) 11/04/2002
K091985 IVY BIOMEDICAL SYSTEMS, INC. UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE 07/24/2009
K992413 MEDICAL DATA ELECTRONICS ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR 08/19/1999
K992411 MEDICAL DATA ELECTRONICS ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR 08/18/1999
K965158 N.P.N.T., INC. HEART PROTECTOR (VER 1996) 12/09/1997
K960544 NASIFF ASSOC., INC. CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM 08/07/1996
K212143 Neteera Technologies Ltd. Neteera 130H/131H Vital Sign Monitoring Sensor 09/28/2022
K952790 NIAN-CRAE, INC. LOG-A-RYTHM MODEL 100 AND MODEL 1001 10/17/1996
K973918 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES 01/13/1998
K043517 NIHON KOHDEN AMERICA, INC. TRANSMITTER, ZS-940PA SERIES 02/03/2005
K063735 PRESYM, INC. PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 09/19/2007
K002725 PROTOCOL SYSTEMS, INC. MICROPAQ, MODELS 402 AND 404 11/21/2000
K950688 SAFETY TEK CORP. OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM 04/18/1996
K963576 SCIENTIFIC APPLICATIONS MOBILE MEDICAL MONITOR (M3(A)) 02/28/1997
K032733 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD PM-8000 PATIENT MONITOR, MODEL 8000 03/03/2004
K020144 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS INFINITY SC 6002XL MODIFICATIONS 02/15/2002
K223163 Sleepiz AG Sleepiz One+ 08/18/2023
K150992 VIOS MEDICAL, INC. Vios Monitoring System 12/16/2015
K172586 Vios Medical, Inc. Vios Monitoring SystemÖ Model 2050 06/22/2018
K021681 WELCH ALLYN PROTOCOL, INC. MICROPAQ, MODELS 402, 404 07/23/2002
K012451 WELCH ALLYN PROTOCOL, INC. PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 08/20/2001
K984033 WELCH ALLYN, INC. ATLAS MONITOR 07/08/1999
K082626 WIRELESS 2000 RF & UWB TECHNOLOGIES LTD. PAM 3000 01/16/2009
K092809 WR MEDICAL ELECTRONICS CO. HRV ACQUIRE 10/19/2010
K202464 Xandar Kardian Inc. Vital Sign Monitoring Sensor (Model :XK300) 04/26/2021
K001775 ZOE MEDICAL, INC. ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM 01/12/2001
K102174 ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS ZOLL PROPAQ M 09/15/2010


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