X-Ray Control and Hi-Voltage Generator
FDA 510(k) K921875 · Continental X-Ray Corp.
510(k) numberK921875
Submission
- Device name
- X-Ray Control and Hi-Voltage Generator
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- April 20, 1992
- Decision date
- October 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was X-Ray Control and Hi-Voltage Generator cleared by the FDA?
X-Ray Control and Hi-Voltage Generator (K921875) received a 510(k) decision of Substantially Equivalent on October 15, 1992, 178 days after the submission was received.
What is the product code of K921875?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.