Allura Xper FD10
FDA 510(k) K041949 · Philips Medical Systems North America Co.
510(k) numberK041949
Submission
- Device name
- Allura Xper FD10
- Applicant
- Philips Medical Systems North America Co.
The Netherlands, NL - Received
- July 20, 2004
- Decision date
- July 30, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Allura Xper FD10 cleared by the FDA?
Allura Xper FD10 (K041949) received a 510(k) decision of Substantially Equivalent on July 30, 2004, 10 days after the submission was received.
What is the product code of K041949?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.