Neurometrix Bioamplifier
510(k) K083322
Neurometrix Bioamplifier is a medical device (FDA Class II; FDA product code GWL, Amplifier, Physiological Signal) made by Neurometrix, Inc., cleared under FDA 510(k) K083322 on 27 May 2009, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083322 | Date27 May 2009 | StatusActive |
Official records
- FDA 510(k) database K083322
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GWL
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1835
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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