Generator, High Volt, X-Ray, Diag. MPX80
FDA 510(k) K802548 · General Electric Co.
510(k) numberK802548
Submission
- Device name
- Generator, High Volt, X-Ray, Diag. MPX80
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- October 15, 1980
- Decision date
- December 2, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Generator, High Volt, X-Ray, Diag. MPX80 cleared by the FDA?
Generator, High Volt, X-Ray, Diag. MPX80 (K802548) received a 510(k) decision of Substantially Equivalent on December 2, 1980, 48 days after the submission was received.
What is the product code of K802548?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.