Eagle 4000 Patient Monitor
FDA 510(k) K964750 · Marquette Electronics, Inc.
510(k) numberK964750
Submission
- Device name
- Eagle 4000 Patient Monitor
- Applicant
- Marquette Electronics, Inc.
Milwaukee, WI, US - Received
- November 26, 1996
- Decision date
- February 21, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
No product code recorded.
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More from Nihon Kohden America, Inc.
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| 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 |
| 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 Eagle 4000 Patient Monitor cleared by the FDA?
Eagle 4000 Patient Monitor (K964750) received a 510(k) decision of Substantially Equivalent on February 21, 1997, 87 days after the submission was received.