Electric Drill System [Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)]
FDA 510(k) K081475 · Medtronic Xomed, Inc.
510(k) numberK081475
Submission
- Device name
- Electric Drill System [Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)]
- Applicant
- Medtronic Xomed, Inc.
Jacksonville, FL, US - Received
- May 27, 2008
- Decision date
- October 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Electric Drill System [Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] cleared by the FDA?
Electric Drill System [Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] (K081475) received a 510(k) decision of Substantially Equivalent on October 17, 2008, 143 days after the submission was received.
What is the product code of K081475?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.