Arc Series
FDA 510(k) K954581 · Continental X-Ray Corp.
510(k) numberK954581
Submission
- Device name
- Arc Series
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- October 2, 1995
- Decision date
- December 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Arc Series cleared by the FDA?
Arc Series (K954581) received a 510(k) decision of Substantially Equivalent on December 21, 1995, 80 days after the submission was received.
What is the product code of K954581?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.