Cardiac Stress Table, 056-180/UNIV Roll Stress Att
FDA 510(k) K926082 · Biodan Medical Systems, Ltd.
510(k) numberK926082
Submission
- Device name
- Cardiac Stress Table, 056-180/UNIV Roll Stress Att
- Applicant
- Biodan Medical Systems, Ltd.
Shirley, NY, US - Received
- December 1, 1992
- Decision date
- December 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Cardiac Stress Table, 056-180/UNIV Roll Stress Att cleared by the FDA?
Cardiac Stress Table, 056-180/UNIV Roll Stress Att (K926082) received a 510(k) decision of Substantially Equivalent on December 30, 1992, 29 days after the submission was received.
What is the product code of K926082?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.