Classic-Ii 4-WAY Horizontal Table Cat.# T-9111
FDA 510(k) K912516 · Continental X-Ray Corp.
510(k) numberK912516
Submission
- Device name
- Classic-Ii 4-WAY Horizontal Table Cat.# T-9111
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- June 6, 1991
- Decision date
- November 19, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Classic-Ii 4-WAY Horizontal Table Cat.# T-9111 cleared by the FDA?
Classic-Ii 4-WAY Horizontal Table Cat.# T-9111 (K912516) received a 510(k) decision of Substantially Equivalent on November 19, 1991, 166 days after the submission was received.
What is the product code of K912516?
The FDA product code is IZZ – Table, Radiographic, Non-Tilting, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.1980.