The following data is part of a premarket notification filed by Microprobes For Life Science, Inc. Dba Neuron with the FDA for Accupoint Electrode.
| Device ID | K162459 |
| 510k Number | K162459 |
| Device Name: | AccuPoint Electrode |
| Classification | Electrode, Depth |
| Applicant | MICROPROBES FOR LIFE SCIENCE, INC. DBA NEURON 18247-D FLOWER HILL WAY Gaithersburg, MD 20879 |
| Contact | Martin Bak |
| Correspondent | Julie Stephens REGULATORY RESOURCES GROUP, INC. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-02 |
| Decision Date | 2017-06-15 |
| Summary: | summary |