Vidicam 200
FDA 510(k) K812613 · Diversified P.A.
510(k) numberK812613
Submission
- Device name
- Vidicam 200
- Applicant
- Diversified P.A.
Mchenry, IL, US - Received
- September 15, 1981
- Decision date
- December 8, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Vidicam 200 cleared by the FDA?
Vidicam 200 (K812613) received a 510(k) decision of Substantially Equivalent on December 8, 1981, 84 days after the submission was received.
What is the product code of K812613?
The FDA product code is IZJ – Camera, X-Ray, Fluorographic, Cine Or Spot, a Class II (moderate risk) device regulated under 21 CFR 892.1620.