Universal Electrodes
FDA 510(k) K081871 · Neurometrix, Inc.
510(k) numberK081871
Submission
- Device name
- Universal Electrodes
- Applicant
- Neurometrix, Inc.
Waltham, MA, US - Received
- July 1, 2008
- Decision date
- September 29, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Universal Electrodes cleared by the FDA?
Universal Electrodes (K081871) received a 510(k) decision of Substantially Equivalent on September 29, 2008, 90 days after the submission was received.
What is the product code of K081871?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.