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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
