Video Plus with Analytical Workstation
FDA 510(k) K941979 · Camtronics, Ltd.
510(k) numberK941979
Submission
- Device name
- Video Plus with Analytical Workstation
- Applicant
- Camtronics, Ltd.
Hartland, WI, US - Received
- April 25, 1994
- Decision date
- August 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Video Plus with Analytical Workstation cleared by the FDA?
Video Plus with Analytical Workstation (K941979) received a 510(k) decision of Substantially Equivalent on August 17, 1994, 114 days after the submission was received.
What is the product code of K941979?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.