Caas II
FDA 510(k) K945540 · Pie Medical Equipment B.V.
510(k) numberK945540
Submission
- Device name
- Caas II
- Applicant
- Pie Medical Equipment B.V.
Maastricht, NL - Received
- November 14, 1994
- Decision date
- June 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Surgvision GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K982203 | Caas II Lva Biplane OptionIZI · Traditional | 07/14/1998SE |
| K915647 | Diagnostic Ultrasound System Model SC250ITX · Traditional | 11/09/1992SE |
| K912819 | SC1150 Cw/PdIYN · Traditional | 01/09/1992SE |
| K911584 | Diagnostic Ultrasound System Model SC480IYO · Traditional | 10/24/1991SE |
| K911043 | Hemisphere Multiplane Endorectal ProbeITX · Traditional | 10/09/1991SE |
| K911044 | 7.5 MHZ Apas Transducer (Art.Nol: 50.04918.1)ITX · Traditional | 10/07/1991SE |
| K900838 | Transvaginal Transducer AssemblyHGL · Traditional | 05/23/1990SE |
Questions and answers
When was Caas II cleared by the FDA?
Caas II (K945540) received a 510(k) decision of Substantially Equivalent on June 28, 1995, 226 days after the submission was received.
What is the product code of K945540?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.