Dragon LW
FDA 510(k) K121410 · Sedecal., Sa.
510(k) numberK121410
Submission
- Device name
- Dragon LW
- Applicant
- Sedecal., Sa.
Naples, FL, US - Received
- May 11, 2012
- Decision date
- August 2, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Dragon LW cleared by the FDA?
Dragon LW (K121410) received a 510(k) decision of Substantially Equivalent on August 2, 2012, 83 days after the submission was received.
What is the product code of K121410?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.