Logiqbook
FDA 510(k) K014206 · General Electric Co.
510(k) numberK014206
Submission
- Device name
- Logiqbook
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- December 21, 2001
- Decision date
- January 16, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Logiqbook cleared by the FDA?
Logiqbook (K014206) received a 510(k) decision of Substantially Equivalent on January 16, 2002, 26 days after the submission was received.
What is the product code of K014206?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.