Trophypan C with Orthoimaging/Omsimaging Accessory
FDA 510(k) K040556 · Eastman Kodak Company
510(k) numberK040556
Submission
- Device name
- Trophypan C with Orthoimaging/Omsimaging Accessory
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- March 2, 2004
- Decision date
- April 7, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Trophypan C with Orthoimaging/Omsimaging Accessory cleared by the FDA?
Trophypan C with Orthoimaging/Omsimaging Accessory (K040556) received a 510(k) decision of Substantially Equivalent on April 7, 2004, 36 days after the submission was received.
What is the product code of K040556?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.