Zymed Telemetry System, Model Easi View
FDA 510(k) K984089 · Zymed Medical Instrumentation
510(k) numberK984089
Submission
- Device name
- Zymed Telemetry System, Model Easi View
- Applicant
- Zymed Medical Instrumentation
Camarillo, CA, US - Received
- November 16, 1998
- Decision date
- February 16, 1999
- 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 |
|---|---|---|
| K002004 | ZybitDXH · Traditional | 09/21/2000SE |
| K992197 | Modification to Zymed Holter 2000MLO · Special | 07/28/1999SE |
| K990170 | Holter 2000MLO · Special | 04/13/1999SE |
| K955015 | Zymed Holter Scanner Model 2010DQK · Traditional | 03/18/1996SE |
| K951370 | Zymed Telemetry System; Model T8010DSI · Traditional | 10/06/1995SE |
| K930894 | Multitrak-PlusDSH · Traditional | 11/01/1993SE |
Questions and answers
When was Zymed Telemetry System, Model Easi View cleared by the FDA?
Zymed Telemetry System, Model Easi View (K984089) received a 510(k) decision of Substantially Equivalent on February 16, 1999, 92 days after the submission was received.
What is the product code of K984089?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.