Alarm Display Unit/Pager-Lan System (Adu)
FDA 510(k) K962827 · Marquette Electronics, Inc.
510(k) numberK962827
Submission
- Device name
- Alarm Display Unit/Pager-Lan System (Adu)
- Applicant
- Marquette Electronics, Inc.
Milwaukee, WI, US - Received
- July 19, 1996
- Decision date
- February 24, 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
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 |
|---|---|---|
| K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMSX · Traditional | 11/13/1997SE |
| K971683 | Wireless Lan (Local Area Network) - Wireless EthernetMSX · Traditional | 10/22/1997SE |
| K972199 | Signal-Averaged High Resolution P Wave AnalysisDPS · Traditional | 09/25/1997SE |
| K962547 | Cardioserv PDRO · Traditional | 03/06/1997SE |
| K963120 | Responder 2500 Defibrillator and Cardiac Care SystemDRO · Traditional | 02/28/1997SE |
| K964750 | Eagle 4000 Patient MonitorLOS · Traditional | 02/21/1997SE |
| K962551 | Cardioserv SLDD · Traditional | 11/19/1996ST |
| K960418 | Eagle Patient MonitorDSI · Traditional | 10/02/1996SE |
| K960272 | Eagle 3000/3100 Patient MonitorMLD · Traditional | 10/02/1996SE |
| K961139 | Eagle Patient Monitor Model 3000/3100DSI · Traditional | 08/09/1996SE |
Questions and answers
When was Alarm Display Unit/Pager-Lan System (Adu) cleared by the FDA?
Alarm Display Unit/Pager-Lan System (Adu) (K962827) received a 510(k) decision of Substantially Equivalent on February 24, 1997, 220 days after the submission was received.
What is the product code of K962827?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.