Overhead Tube Mount Cascade II
FDA 510(k) K880528 · Fischer Imaging Corp.
510(k) numberK880528
Submission
- Device name
- Overhead Tube Mount Cascade II
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- February 9, 1988
- Decision date
- February 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Overhead Tube Mount Cascade II cleared by the FDA?
Overhead Tube Mount Cascade II (K880528) received a 510(k) decision of Substantially Equivalent on February 29, 1988, 20 days after the submission was received.
What is the product code of K880528?
The FDA product code is IYB – Tube Mount, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1770.