Pde-Neo
FDA 510(k) K133719 · Hamamatsu Photonics K.K.
510(k) numberK133719
Submission
- Device name
- Pde-Neo
- Applicant
- Hamamatsu Photonics K.K.
Washington Dc, DC, US - Received
- December 5, 2013
- Decision date
- March 27, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Pde-Neo cleared by the FDA?
Pde-Neo (K133719) received a 510(k) decision of Substantially Equivalent on March 27, 2014, 112 days after the submission was received.
What is the product code of K133719?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.