Omega II Angiographic Table
FDA 510(k) K812913 · General Electric Co.
510(k) numberK812913
Submission
- Device name
- Omega II Angiographic Table
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- October 19, 1981
- Decision date
- November 24, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Omega II Angiographic Table cleared by the FDA?
Omega II Angiographic Table (K812913) received a 510(k) decision of Substantially Equivalent on November 24, 1981, 36 days after the submission was received.
What is the product code of K812913?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.