Compax Model 40, 400, 400T
FDA 510(k) K884930 · General Electric Co.
510(k) numberK884930
Submission
- Device name
- Compax Model 40, 400, 400T
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- November 25, 1988
- Decision date
- December 22, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Compax Model 40, 400, 400T cleared by the FDA?
Compax Model 40, 400, 400T (K884930) received a 510(k) decision of Substantially Equivalent on December 22, 1988, 27 days after the submission was received.
What is the product code of K884930?
The FDA product code is IZZ – Table, Radiographic, Non-Tilting, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.1980.