Damon D.E.T.E.C.T Image Enhancer
FDA 510(k) K874865 · Damon Corp.
510(k) numberK874865
Submission
- Device name
- Damon D.E.T.E.C.T Image Enhancer
- Applicant
- Damon Corp.
North Attleboro, MA, US - Received
- November 27, 1987
- Decision date
- December 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Damon D.E.T.E.C.T Image Enhancer cleared by the FDA?
Damon D.E.T.E.C.T Image Enhancer (K874865) received a 510(k) decision of Substantially Equivalent on December 23, 1987, 26 days after the submission was received.
What is the product code of K874865?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.