FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL ELECTRODES
K Number: K083818
·
Decision Jan 21, 2009
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
18
Review Days
30
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Basic Information
- Device Name
- UNIVERSAL ELECTRODES
- K Number
- K083818
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurometrix, Inc.
- Date Received
- December 22, 2008
- Decision Date
- January 21, 2009
- Product Code
- GXY
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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Other Clearances by Neurometrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN210046 | Quell-FM | May 18, 2022 | Unknown |
| K152954 | Quell | Jan 5, 2016 | Substantially Equivalent |
| K140586 | ASCEND ELECTRODE | Nov 17, 2014 | Substantially Equivalent |
| K140333 | ASCEND | Jul 3, 2014 | Substantially Equivalent |
| K130919 | SENSUS | Jul 2, 2013 | Substantially Equivalent |
| K121816 | SENSUS ELECTRODE | Nov 26, 2012 | Substantially Equivalent |
| K121184 | SENSUS | Aug 2, 2012 | Substantially Equivalent |
| K091155 | ASCEND | Sep 3, 2009 | Substantially Equivalent |
| K083322 | NEUROMETRIX BIOAMPLIFIER | May 27, 2009 | Substantially Equivalent |
| K081871 | UNIVERSAL ELECTRODES | Sep 29, 2008 | Substantially Equivalent |