K083322 is an FDA 510(k) clearance for the NEUROMETRIX BIOAMPLIFIER. This device is classified as a Amplifier, Physiological Signal (Class II - Special Controls, product code GWL).
Submitted by Neurometrix, Inc. (Waltham, US). The FDA issued a Cleared decision on May 27, 2009, 196 days after receiving the submission on November 12, 2008.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1835.
| 510(k) Number | K083322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2008 |
| Decision Date | May 27, 2009 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWL - Amplifier, Physiological Signal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1835 |