Clearvision
FDA 510(k) K112380 · Midmark Corp.
510(k) numberK112380
Submission
- Device name
- Clearvision
- Applicant
- Midmark Corp.
Lincolnshire, IL, US - Received
- August 17, 2011
- Decision date
- November 22, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Clearvision cleared by the FDA?
Clearvision (K112380) received a 510(k) decision of Substantially Equivalent on November 22, 2011, 97 days after the submission was received.
What is the product code of K112380?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.