Image Intensifier Tube W/Housing &
FDA 510(k) K833641 · Varian Assoc., Inc.
510(k) numberK833641
Submission
- Device name
- Image Intensifier Tube W/Housing &
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- October 17, 1983
- Decision date
- December 30, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Image Intensifier Tube W/Housing & cleared by the FDA?
Image Intensifier Tube W/Housing & (K833641) received a 510(k) decision of Substantially Equivalent on December 30, 1983, 74 days after the submission was received.
What is the product code of K833641?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.