Subdural Strip Electrode
FDA 510(k) K021144 · Nicolet Biomedical, Inc.
510(k) numberK021144
Submission
- Device name
- Subdural Strip Electrode
- Applicant
- Nicolet Biomedical, Inc.
Stoughton, WI, US - Received
- April 9, 2002
- Decision date
- June 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Subdural Strip Electrode cleared by the FDA?
Subdural Strip Electrode (K021144) received a 510(k) decision of Substantially Equivalent on June 24, 2002, 76 days after the submission was received.
What is the product code of K021144?
The FDA product code is GYC – Electrode, Cortical, a Class II (moderate risk) device regulated under 21 CFR 882.1310.