Pro-Top-Angio Shift Table Top Extension
FDA 510(k) K810183 · Philips Medical Systems (Cleveland), Inc.
510(k) numberK810183
Submission
- Device name
- Pro-Top-Angio Shift Table Top Extension
- Applicant
- Philips Medical Systems (Cleveland), Inc.
Mchenry, IL, US - Received
- January 22, 1981
- Decision date
- February 25, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Pro-Top-Angio Shift Table Top Extension cleared by the FDA?
Pro-Top-Angio Shift Table Top Extension (K810183) received a 510(k) decision of Substantially Equivalent on February 25, 1981, 34 days after the submission was received.
What is the product code of K810183?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.