G.E. Fluorocon 300 Imaging System
FDA 510(k) K902981 · Electromek Diagnostic Systems, Inc.
510(k) numberK902981
Submission
- Device name
- G.E. Fluorocon 300 Imaging System
- Applicant
- Electromek Diagnostic Systems, Inc.
Troy, IL, US - Received
- June 26, 1990
- Decision date
- November 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was G.E. Fluorocon 300 Imaging System cleared by the FDA?
G.E. Fluorocon 300 Imaging System (K902981) received a 510(k) decision of Substantially Equivalent on November 7, 1990, 134 days after the submission was received.
What is the product code of K902981?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.