ADX4000-L, DX3000-L
FDA 510(k) K083532 · Dexcowin Co., Ltd.
510(k) numberK083532
Submission
- Device name
- ADX4000-L, DX3000-L
- Applicant
- Dexcowin Co., Ltd.
Seoul, KR - Received
- November 28, 2008
- Decision date
- March 10, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ADX4000-L, DX3000-L cleared by the FDA?
ADX4000-L, DX3000-L (K083532) received a 510(k) decision of Substantially Equivalent on March 10, 2009, 102 days after the submission was received.
What is the product code of K083532?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.