Product code DSI
- Device name
- Detector And Alarm, Arrhythmia
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1025
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | 2026-01-23 |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Infobionic, Inc. | 2025-07-29 |
| K240177 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | 2024-10-30 |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | 2023-10-06 |
| K231276 | SmartCardia 7L Platform | Smartcardia SA | 2023-08-30 |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | Medicalgorithmics S.A. | 2020-04-09 |
| K192732 | BodyGuardian Remote Monitoring System | Preventice Technologies, Inc. | 2020-03-26 |
| K190574 | Patient Assistant Model PA97000 | Medtronic, Inc. | 2019-09-24 |
| K182532 | Liba3 System | National Cardiac, Inc. | 2019-05-15 |
| K181658 | MobileECG 2 BT | Memtec Corporation | 2019-03-26 |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | Medicalgorithmics S.A. | 2018-07-11 |
| K173170 | Epicardia Anywhere | Medicomp, Inc. | 2018-01-10 |
| K153473 | Braemar Telemetry Patch System | Braemar Manufacturing, LLC | 2016-07-22 |
| K153477 | EMMa Electronic Monitoring Management | Vitasystems GmbH | 2016-05-25 |
| K152701 | Matrix Mini ECG Monitor | Global Instrumentation, LLC | 2016-04-22 |
| K152305 | Nihon Kohden Afib Detection Program QP-039P | Nihon Kohden Corporation | 2016-04-08 |
| K151835 | Vital Signs Patch System | Lifewatch Technologies , Ltd. | 2016-02-05 |
| K151269 | ECG Mini System Continuous ECG Monitor and Arrhythmia Detector | Lifewatch Technologies , Ltd. | 2016-01-15 |
| K152491 | MoMe Software Platform | Infobionic, Inc. | 2015-12-17 |
| K152550 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM | Medicalgorithmics S.A. | 2015-10-08 |
| K151188 | BodyGuardian Remote Monitoring System | Preventice | 2015-09-17 |
| K143359 | CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector | Lifewatch Technologies , Ltd. | 2015-09-11 |
| K151681 | IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2015-07-17 |
| K150117 | Medtronic Patient Asistant | Medtronic, Inc. | 2015-05-27 |
| K150310 | IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2015-05-13 |
| K142352 | CardiacLinx | Ross Medical Technology, Inc. | 2015-03-12 |
| K141441 | MENNTOR X7 | Mennen Medical , Ltd. | 2015-01-09 |
| K132407 | VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) | Lifewatch Technologies , Ltd. | 2014-12-19 |
| K142180 | TELESENSE | Scottcare Corporation | 2014-12-12 |
| K140548 | CORCAM HEART MONITOR | Corcam Technologia, SA | 2014-05-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10841522107788 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-03-10 |
| 10841522107771 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-03-10 |
| 10841522103957 | STATCORP MEDICAL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-03-06 |
| 10841522102509 | Trulink | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-02-08 |
| 10841522102875 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-02-03 |
| 10841522120190 | Xhibit Telemetry Receiver | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-23 |
| 10841522120220 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-06 |
| 10841522120213 | Ultraview SL® | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-06 |
| 10841522102707 | XTR | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522120206 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522102714 | XTR | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522102721 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-22 |
| 10841522102738 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-22 |
| 10841522102868 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-22 |
| 10841522102691 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-22 |
| 10841522101892 | Trulink | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-20 |
| 10841522101885 | Trulink | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-20 |
| 10841522101878 | Trulink | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-20 |
| 10841522101847 | Trulink | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-20 |
| 10841522100598 | Trulink | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-20 |
| 10841522108778 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-11-15 |
| 10841522108785 | Spacelabs | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-11-15 |
| 10841522108792 | Spacelabs | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-11-15 |
| 10841522106422 | Ultraview SL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-07 |
| 10841522106439 | Ultraview SL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-07 |
| 10841522100345 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-04 |
| 10841522107832 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-04 |
| 10841522100246 | Xhibit Telemetry Receiver | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-09-22 |
| 10841522107177 | XTR | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-09-22 |
| 10841522106514 | XTR | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-09-22 |