Fluoroscopic Automatic Brightness CNTL
FDA 510(k) K843917 · Afp Imaging Corp.
510(k) numberK843917
Submission
- Device name
- Fluoroscopic Automatic Brightness CNTL
- Applicant
- Afp Imaging Corp.
Chatsworth, CA, US - Received
- October 5, 1984
- Decision date
- January 3, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Fluoroscopic Automatic Brightness CNTL cleared by the FDA?
Fluoroscopic Automatic Brightness CNTL (K843917) received a 510(k) decision of Substantially Equivalent on January 3, 1985, 90 days after the submission was received.
What is the product code of K843917?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.