X-Ray Angiographic System
FDA 510(k) K934496 · Camtronics, Ltd.
510(k) numberK934496
Submission
- Device name
- X-Ray Angiographic System
- Applicant
- Camtronics, Ltd.
Hartland, WI, US - Received
- September 15, 1993
- Decision date
- December 13, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was X-Ray Angiographic System cleared by the FDA?
X-Ray Angiographic System (K934496) received a 510(k) decision of Substantially Equivalent on December 13, 1993, 89 days after the submission was received.
What is the product code of K934496?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.