Model TM Ep High Voltage Generator
FDA 510(k) K942100 · Continental X-Ray Corp.
510(k) numberK942100
Submission
- Device name
- Model TM Ep High Voltage Generator
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- April 26, 1994
- Decision date
- June 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Model TM Ep High Voltage Generator cleared by the FDA?
Model TM Ep High Voltage Generator (K942100) received a 510(k) decision of Substantially Equivalent on June 7, 1994, 42 days after the submission was received.
What is the product code of K942100?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.