Ic-Pro System, Version 3.1.0.4
FDA 510(k) K082907 · Paieon, Inc.
510(k) numberK082907
Submission
- Device name
- Ic-Pro System, Version 3.1.0.4
- Applicant
- Paieon, Inc.
Rosh Haayin, IL - Received
- September 30, 2008
- Decision date
- November 18, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ic-Pro System, Version 3.1.0.4 cleared by the FDA?
Ic-Pro System, Version 3.1.0.4 (K082907) received a 510(k) decision of Substantially Equivalent on November 18, 2008, 49 days after the submission was received.
What is the product code of K082907?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.