Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane Series
FDA 510(k) K130842 · Philips Medical Systems Nederland B.V.
510(k) numberK130842
Submission
- Device name
- Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane Series
- Applicant
- Philips Medical Systems Nederland B.V.
Best Noord-Brabant, NL - Received
- March 27, 2013
- Decision date
- May 21, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane Series cleared by the FDA?
Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane Series (K130842) received a 510(k) decision of Substantially Equivalent on May 21, 2013, 55 days after the submission was received.
What is the product code of K130842?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.