Omega III Angiographic Table, Rotation & Stepper
FDA 510(k) K871827 · General Electric Co.
510(k) numberK871827
Submission
- Device name
- Omega III Angiographic Table, Rotation & Stepper
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- May 11, 1987
- Decision date
- June 19, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Omega III Angiographic Table, Rotation & Stepper cleared by the FDA?
Omega III Angiographic Table, Rotation & Stepper (K871827) received a 510(k) decision of Substantially Equivalent on June 19, 1987, 39 days after the submission was received.
What is the product code of K871827?
The FDA product code is KXJ – Table, Radiologic, a Class II (moderate risk) device regulated under 21 CFR 892.1980.