Product code DRT
- Device name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2300
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261286 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026-05-20 |
| K252676 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026-02-03 |
| K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | 2026-01-28 |
| K251364 | Sleepiz One+ (2.5) | Sleepiz AG | 2025-07-29 |
| K234003 | The Circadia C200 System | Circadia Technologies, Ltd. | 2024-05-30 |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | Murata Vios, Inc. | 2024-03-22 |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | 2024-02-09 |
| K223163 | Sleepiz One+ | Sleepiz AG | 2023-08-18 |
| K212143 | Neteera 130H/131H Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | 2022-09-28 |
| K202138 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2021-05-14 |
| K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021-04-26 |
| K181165 | Philips wearable biosensor-G5 Solution | Connected Sensing- A Division of Philips Medical Systems | 2019-03-07 |
| K172586 | Vios Monitoring System™ Model 2050 | Vios Medical, Inc. | 2018-06-22 |
| K170828 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2017-05-17 |
| K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | Ivy Biomedical Systems, Inc. | 2016-05-27 |
| K150992 | Vios Monitoring System | Vios Medical, Inc. | 2015-12-16 |
| K121860 | ESA615 | Fluke Biomedical | 2013-01-25 |
| K121722 | ESA620 ELECTRICAL SAFETY ANALYZER | Fluke Biomedical | 2012-10-11 |
| K110429 | PROSIM 4, PROSIM 6, PROSIM 8 | Fluke Biomedical | 2011-09-02 |
| K110987 | CARDIAC TRIGGER MONITOR | Ivy Biomedical Systems, Inc. | 2011-07-22 |
| K103336 | MPS450 MULTIPARAMETER SIMULATOR | Fluke Biomedical | 2011-04-13 |
| K092809 | HRV ACQUIRE | Wr Medical Electronics Co. | 2010-10-19 |
| K102174 | ZOLL PROPAQ M | Zoll Medical Corporation, World Wide Headquarters | 2010-09-15 |
| K100745 | LIFEBED NETWORK PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2010-04-15 |
| K092037 | LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2009-10-02 |
| K091985 | UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE | Ivy Biomedical Systems, Inc. | 2009-07-24 |
| K091050 | 506CN PATIENT MONITOR | Criticare Systems, Inc. | 2009-05-27 |
| K083534 | LIFEBED NETWORK PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2009-04-13 |
| K083854 | CARDIAC TRIGGER, MODEL: CTM300 | Ivy Biomedical Systems, Inc. | 2009-02-13 |
| K082626 | PAM 3000 | Wireless 2000 RF & Uwb Technologies , Ltd. | 2009-01-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B3944670047010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700068020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700064010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700063010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700051020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048100 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048090 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048080 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048070 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048060 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048050 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048030 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3944060056010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945000030010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300046010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300054010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300054020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945600013020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048040 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| 08809988780049 | Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E) | Xandar Kardian Korea Inc. | 2025-12-04 |
| 07649996477019 | Sleepiz One+ | Sleepiz AG | 2024-05-14 |
| 08809988780001 | Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300) | Xandar Kardian Korea Inc. | 2024-01-19 |
| 08719327003770 | Finapres | Finapres Medical Systems B.V. | 2018-11-30 |
| 08719327007105 | Finapres | Finapres Medical Systems B.V. | 2018-11-30 |
| 10841983102704 | BluPRO® | NIHON KOHDEN AMERICA, INC. | 2016-09-19 |
| 10841983102711 | BluPRO® | NIHON KOHDEN AMERICA, INC. | 2016-09-19 |
| 10841983102728 | BluPRO® | NIHON KOHDEN AMERICA, INC. | 2016-09-19 |
| 10841983102735 | BluPRO® | NIHON KOHDEN AMERICA, INC. | 2016-09-19 |