Cerebralogik- Aeeg
FDA 510(k) K131789 · Mennen Medical , Ltd.
510(k) numberK131789
Submission
- Device name
- Cerebralogik- Aeeg
- Applicant
- Mennen Medical , Ltd.
Rohovot, IL - Received
- June 18, 2013
- Decision date
- December 27, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMA – Amplitude-Integrated Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
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Questions and answers
When was Cerebralogik- Aeeg cleared by the FDA?
Cerebralogik- Aeeg (K131789) received a 510(k) decision of Substantially Equivalent on December 27, 2013, 192 days after the submission was received.
What is the product code of K131789?
The FDA product code is OMA – Amplitude-Integrated Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.