The following data is part of a premarket notification filed by Neurometrix, Inc. with the FDA for Neurometrix Bioamplifier.
| Device ID | K083322 |
| 510k Number | K083322 |
| Device Name: | NEUROMETRIX BIOAMPLIFIER |
| Classification | Amplifier, Physiological Signal |
| Applicant | NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451 |
| Contact | Rainer Maas |
| Correspondent | Rainer Maas NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-12 |
| Decision Date | 2009-05-27 |
| Summary: | summary |