Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core Mobile
FDA 510(k) K133641 · Volcano Corporation
510(k) numberK133641
Submission
- Device name
- Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core Mobile
- Applicant
- Volcano Corporation
Billerica, MA, US - Received
- November 27, 2013
- Decision date
- December 20, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core Mobile cleared by the FDA?
Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core Mobile (K133641) received a 510(k) decision of Substantially Equivalent on December 20, 2013, 23 days after the submission was received.
What is the product code of K133641?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.