Dvas (Dvas-M, Dvas-W)
FDA 510(k) K232085 · Genoray Co., Ltd.
510(k) numberK232085
Submission
- Device name
- Dvas (Dvas-M, Dvas-W)
- Applicant
- Genoray Co., Ltd.
Seongnam-Si, KR - Received
- July 13, 2023
- Decision date
- December 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Dvas (Dvas-M, Dvas-W) cleared by the FDA?
Dvas (Dvas-M, Dvas-W) (K232085) received a 510(k) decision of Substantially Equivalent on December 8, 2023, 148 days after the submission was received.
What is the product code of K232085?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.