Wireless Lan (Local Area Network) - Wireless Ethernet
FDA 510(k) K971683 · Marquette Electronics, Inc.
510(k) numberK971683
Submission
- Device name
- Wireless Lan (Local Area Network) - Wireless Ethernet
- Applicant
- Marquette Electronics, Inc.
Milwaukee, WI, US - Received
- May 7, 1997
- Decision date
- October 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K242728 | BeneVision Central Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/31/2025SE |
| K242750 | Central StationMSX · Traditional | Nihon Kohden Digital Health Solutions, LLC | 06/05/2025SE |
| K242842 | ANNE View, Central HubMSX · Traditional | Sibel Health, Inc. | 01/08/2025SE |
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More from Draeger Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMSX · Traditional | 11/13/1997SE |
| 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 |
| K962827 | Alarm Display Unit/Pager-Lan System (Adu)DSI · Traditional | 02/24/1997SE |
| 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 Wireless Lan (Local Area Network) - Wireless Ethernet cleared by the FDA?
Wireless Lan (Local Area Network) - Wireless Ethernet (K971683) received a 510(k) decision of Substantially Equivalent on October 22, 1997, 168 days after the submission was received.
What is the product code of K971683?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.