510(k) K934913
- Device
- HEARTRAC ECG MONITORING SYSTEM
- Applicant
- CARDIAC TELECOM CORP.
- 510(k) number
- K934913
- Product code
- DSI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-06-05
- Date received
- 1993-10-15
- Regulation
- 870.1025
- Classification name
- Detector And Alarm, Arrhythmia
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- JONATHAN S KAHAN
- Address
- Columbia Sq. 555 Thirteenth St., NW Washington, D.C. DC US 20004 20004
FDA Registration Numbers
- 3003832357
- 3012104670
- 3015997711
Source Documents
Other 510(k) Records For Product Code DSI
| 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 |
Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases