Cardiop-B System, Version 2.1
FDA 510(k) K072591 · Paieon, Inc.
510(k) numberK072591
Submission
- Device name
- Cardiop-B System, Version 2.1
- Applicant
- Paieon, Inc.
Rosh Haayin, IL - Received
- September 14, 2007
- Decision date
- October 10, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Cardiop-B System, Version 2.1 cleared by the FDA?
Cardiop-B System, Version 2.1 (K072591) received a 510(k) decision of Substantially Equivalent on October 10, 2007, 26 days after the submission was received.
What is the product code of K072591?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.