Escort-Link Arrhythmia Option 23L
FDA 510(k) K915153 · Medical Data Electronics
510(k) numberK915153
Submission
- Device name
- Escort-Link Arrhythmia Option 23L
- Applicant
- Medical Data Electronics
Arleta, CA, US - Received
- November 14, 1991
- Decision date
- April 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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 |
|---|---|---|
| K014294 | Modification to Escort Ii+ 400 Series 9ESCORT Prism) Monitor, Models 20400, 20401…DQA · Special | 01/25/2002SE |
| K012336 | Modification To:Escort Vision Central Station Telemetry System, Model 20500DSI · Special | 10/03/2001SE |
| K000660 | Escort Ii+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411…DRO · Special | 03/28/2000SE |
| K992413 | Escort 100/300 Series B (Escort II) Patient MonitorDRT · Special | 08/19/1999SE |
| K992411 | Escort Ii+ 400 Series (Escort Prism) MonitorDRT · Special | 08/18/1999SE |
| K982104 | Escort-Link Central Station Monitor Model 20500MLD · Special | 11/25/1998SE |
| K970763 | Modular Telemetry System (MTS) Option for the Mde Escort II MonitorDQA · Traditional | 07/14/1997SE |
| K970011 | Escort II Clinical Thermometry Module (CTM)FLL · Traditional | 07/09/1997SE |
| K970012 | Escort Link Central Station MonitorDSI · Traditional | 06/26/1997SE |
| K961138 | Esort II + 400 Series MonitorDRO · Traditional | 12/10/1996SE |
Questions and answers
When was Escort-Link Arrhythmia Option 23L cleared by the FDA?
Escort-Link Arrhythmia Option 23L (K915153) received a 510(k) decision of Substantially Equivalent on April 27, 1992, 165 days after the submission was received.
What is the product code of K915153?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.