Apexpro Telemetry System
FDA 510(k) K000779 · General Electric Medical Systems Information Techn
510(k) numberK000779
Submission
- Device name
- Apexpro Telemetry System
- Applicant
- General Electric Medical Systems Information Techn
Milwaukee, WI, US - Received
- March 10, 2000
- Decision date
- May 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code DSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional | Boston Scientific Cardiac Diagnostic… | 01/23/2026SE |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional | Infobionic, Inc. | 07/29/2025SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | iRhythm Technologies, Inc. | 10/30/2024SE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special | Medicalgorithmics S.A. | 04/09/2020SE |
| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
More from Memtec Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K023380 | T-Wave Altermans (Twa) Algorithm OptionDQK · Traditional | 12/03/2002SE |
| K021470 | Seer Light Compact Digital Holter RecorderMWJ · Traditional | 11/14/2002SE |
| K023100 | Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsLLZ · Special | 10/11/2002SE |
| K021454 | Unity Network IdMWI · Traditional | 10/01/2002SE |
| K020290 | Dash 3000/4000 Patient MonitorMHX · Traditional | 08/14/2002SE |
| K021366 | Mac-Lab/Cardiolab Ep/CombolabDQK · Special | 07/03/2002SE |
| K020661 | Unity Is Patient ViewerMSX · Traditional | 05/24/2002SE |
| K021325 | Modification of Apexpro Telemetry SystemMHX · Special | 05/07/2002SE |
| K020524 | Patientnet Monitoring SystemMSX · Special | 03/20/2002SE |
| K012467 | Solar 8000M SystemDSI · Traditional | 02/11/2002SE |
Questions and answers
When was Apexpro Telemetry System cleared by the FDA?
Apexpro Telemetry System (K000779) received a 510(k) decision of Substantially Equivalent on May 18, 2000, 69 days after the submission was received.
What is the product code of K000779?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.