Sopix 2
FDA 510(k) K092329 · Sopro
510(k) numberK092329
Submission
- Device name
- Sopix 2
- Applicant
- Sopro
Mt. Laurel, NJ, US - Received
- August 4, 2009
- Decision date
- July 20, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Sopix 2 cleared by the FDA?
Sopix 2 (K092329) received a 510(k) decision of Substantially Equivalent on July 20, 2010, 350 days after the submission was received.
What is the product code of K092329?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.