3 Phase High Freq. Diag. X-Ray Gen. Micro-X 60HF
FDA 510(k) K880525 · Fischer Imaging Corp.
510(k) numberK880525
Submission
- Device name
- 3 Phase High Freq. Diag. X-Ray Gen. Micro-X 60HF
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- February 9, 1988
- Decision date
- August 15, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was 3 Phase High Freq. Diag. X-Ray Gen. Micro-X 60HF cleared by the FDA?
3 Phase High Freq. Diag. X-Ray Gen. Micro-X 60HF (K880525) received a 510(k) decision of Substantially Equivalent on August 15, 1988, 188 days after the submission was received.
What is the product code of K880525?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.