The following data is part of a premarket notification filed by Astro-med, Inc. with the FDA for Aura-psg.
| Device ID | K050425 |
| 510k Number | K050425 |
| Device Name: | AURA-PSG |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Contact | Michael J Sullivan |
| Correspondent | Michael J Sullivan ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-18 |
| Decision Date | 2005-10-20 |
| Summary: | summary |