Advantage Sim
FDA 510(k) K951830 · General Electric Co.
510(k) numberK951830
Submission
- Device name
- Advantage Sim
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- April 20, 1995
- Decision date
- November 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Advantage Sim cleared by the FDA?
Advantage Sim (K951830) received a 510(k) decision of Substantially Equivalent on November 13, 1995, 207 days after the submission was received.
What is the product code of K951830?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.