Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for Integrated System,Volcano S5 Precision
FDA 510(k) K133142 · Volcano Corporation
510(k) numberK133142
Submission
- Device name
- Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for Integrated System,Volcano S5 Precision
- Applicant
- Volcano Corporation
Billerica, MA, US - Received
- October 17, 2013
- Decision date
- November 15, 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 Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for Integrated System,Volcano S5 Precision cleared by the FDA?
Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for Integrated System,Volcano S5 Precision (K133142) received a 510(k) decision of Substantially Equivalent on November 15, 2013, 29 days after the submission was received.
What is the product code of K133142?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.