Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP Foot Pedal
FDA 510(k) K080802 · The Anspach Effort, Inc.
510(k) numberK080802
Submission
- Device name
- Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP Foot Pedal
- Applicant
- The Anspach Effort, Inc.
Palm Beach Gardens, FL, US - Received
- March 21, 2008
- Decision date
- April 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP Foot Pedal cleared by the FDA?
Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP Foot Pedal (K080802) received a 510(k) decision of Substantially Equivalent on April 30, 2008, 40 days after the submission was received.
What is the product code of K080802?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.