Ep-X Biplane
FDA 510(k) K961207 · Fischer Imaging Corp.
510(k) numberK961207
Submission
- Device name
- Ep-X Biplane
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- March 27, 1996
- Decision date
- August 20, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Ep-X Biplane cleared by the FDA?
Ep-X Biplane (K961207) received a 510(k) decision of Substantially Equivalent on August 20, 1996, 146 days after the submission was received.
What is the product code of K961207?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.