Escort Link Central Station Monitor
FDA 510(k) K970012 · Medical Data Electronics
510(k) numberK970012
Submission
- Device name
- Escort Link Central Station Monitor
- Applicant
- Medical Data Electronics
Arleta, CA, US - Received
- January 2, 1997
- Decision date
- June 26, 1997
- 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
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| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
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| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
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| 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 |
| K961138 | Esort II + 400 Series MonitorDRO · Traditional | 12/10/1996SE |
| K943256 | Cardiac Output Option 39DXG · Traditional | 12/15/1994SE |
Questions and answers
When was Escort Link Central Station Monitor cleared by the FDA?
Escort Link Central Station Monitor (K970012) received a 510(k) decision of Substantially Equivalent on June 26, 1997, 175 days after the submission was received.
What is the product code of K970012?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.