Advantx Afm Angio System S1808
FDA 510(k) K905653 · GE Medical Systems
510(k) numberK905653
Submission
- Device name
- Advantx Afm Angio System S1808
- Applicant
- GE Medical Systems
Milwaukee, WI, US - Received
- December 18, 1990
- Decision date
- May 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Advantx Afm Angio System S1808 cleared by the FDA?
Advantx Afm Angio System S1808 (K905653) received a 510(k) decision of Substantially Equivalent on May 15, 1991, 148 days after the submission was received.
What is the product code of K905653?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.