Snap EEG Monitor
FDA 510(k) K020218 · Nicolet Biomedical, Inc.
510(k) numberK020218
Submission
- Device name
- Snap EEG Monitor
- Applicant
- Nicolet Biomedical, Inc.
Stoughton, WI, US - Received
- January 22, 2002
- Decision date
- April 22, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLW – Index-Generating Electroencephalograph Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
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Questions and answers
When was Snap EEG Monitor cleared by the FDA?
Snap EEG Monitor (K020218) received a 510(k) decision of Substantially Equivalent on April 22, 2002, 90 days after the submission was received.
What is the product code of K020218?
The FDA product code is OLW – Index-Generating Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.