Inventor Rt/Explorer Trauma Unit
FDA 510(k) K911563 · Continental X-Ray Corp.
510(k) numberK911563
Submission
- Device name
- Inventor Rt/Explorer Trauma Unit
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- April 8, 1991
- Decision date
- October 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Inventor Rt/Explorer Trauma Unit cleared by the FDA?
Inventor Rt/Explorer Trauma Unit (K911563) received a 510(k) decision of Substantially Equivalent on October 23, 1991, 198 days after the submission was received.
What is the product code of K911563?
The FDA product code is IYB – Tube Mount, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1770.