Analytical Review Station
FDA 510(k) K955519 · Camtronics, Ltd.
510(k) numberK955519
Submission
- Device name
- Analytical Review Station
- Applicant
- Camtronics, Ltd.
Hartland, WI, US - Received
- December 4, 1995
- Decision date
- May 9, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Analytical Review Station cleared by the FDA?
Analytical Review Station (K955519) received a 510(k) decision of Substantially Equivalent on May 9, 1996, 157 days after the submission was received.
What is the product code of K955519?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.