The following data is part of a premarket notification filed by Astro-med, Inc. with the FDA for Twin Neurotrac-iii.
| Device ID | K081551 |
| 510k Number | K081551 |
| Device Name: | TWIN NEUROTRAC-III |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Contact | Alfredo Bustamante |
| Correspondent | Alfredo Bustamante ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Product Code | OMA |
| Subsequent Product Code | OLT |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-03 |
| Decision Date | 2008-12-24 |
| Summary: | summary |