Saturne 41
FDA 510(k) K892860 · General Electric Co.
510(k) numberK892860
Submission
- Device name
- Saturne 41
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- April 18, 1989
- Decision date
- June 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Saturne 41 cleared by the FDA?
Saturne 41 (K892860) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 66 days after the submission was received.
What is the product code of K892860?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.