Comet C-125
FDA 510(k) K914748 · Fischer Imaging Corp.
510(k) numberK914748
Submission
- Device name
- Comet C-125
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- October 22, 1991
- Decision date
- October 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Comet C-125 cleared by the FDA?
Comet C-125 (K914748) received a 510(k) decision of Substantially Equivalent on October 15, 1992, 359 days after the submission was received.
What is the product code of K914748?
The FDA product code is OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1650.