Ev Apan Digital, Model K1VSM2000
FDA 510(k) K041120 · Afp Imaging Corp.
510(k) numberK041120
Submission
- Device name
- Ev Apan Digital, Model K1VSM2000
- Applicant
- Afp Imaging Corp.
Elmsford, NY, US - Received
- April 29, 2004
- Decision date
- August 30, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ev Apan Digital, Model K1VSM2000 cleared by the FDA?
Ev Apan Digital, Model K1VSM2000 (K041120) received a 510(k) decision of Substantially Equivalent on August 30, 2004, 123 days after the submission was received.
What is the product code of K041120?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.