GE Brainwave Option(S) for MRI Systems
FDA 510(k) K033867 · General Electric Co.
510(k) numberK033867
Submission
- Device name
- GE Brainwave Option(S) for MRI Systems
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- December 12, 2003
- Decision date
- December 19, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was GE Brainwave Option(S) for MRI Systems cleared by the FDA?
GE Brainwave Option(S) for MRI Systems (K033867) received a 510(k) decision of Substantially Equivalent on December 19, 2003, 7 days after the submission was received.
What is the product code of K033867?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.