Eagle System
FDA 510(k) K912799 · Marquette Electronics, Inc.
510(k) numberK912799
Submission
- Device name
- Eagle System
- Applicant
- Marquette Electronics, Inc.
Milwaukee, WI, US - Received
- June 25, 1991
- Decision date
- December 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K061302 | Digital Printer P6000D Series, Model P6000DULMC · Traditional | Mitsubishi Electric Corporation Kyoto Works | 06/23/2006SE |
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| K964750 | Eagle 4000 Patient MonitorLOS · Traditional | 02/21/1997SE |
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| K960418 | Eagle Patient MonitorDSI · Traditional | 10/02/1996SE |
| K960272 | Eagle 3000/3100 Patient MonitorMLD · Traditional | 10/02/1996SE |
Questions and answers
When was Eagle System cleared by the FDA?
Eagle System (K912799) received a 510(k) decision of Substantially Equivalent on December 18, 1991, 176 days after the submission was received.
What is the product code of K912799?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.