The following data is part of a premarket notification filed by Eb Neuro, S.p.a. with the FDA for Be Micro, Trea.
| Device ID | K093728 |
| 510k Number | K093728 |
| Device Name: | BE MICRO, TREA |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | EB NEURO, S.P.A. 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Contact | Jamie Austin |
| Correspondent | Jamie Austin EB NEURO, S.P.A. 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Product Code | OLV |
| Subsequent Product Code | DQA |
| Subsequent Product Code | GWL |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | MNR |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-03 |
| Decision Date | 2010-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056446900000 | K093728 | 000 |
| 08056446900956 | K093728 | 000 |
| 08056446900949 | K093728 | 000 |
| 08056446900055 | K093728 | 000 |
| 08056446900048 | K093728 | 000 |
| 08056446900031 | K093728 | 000 |
| 08056446900024 | K093728 | 000 |
| 08056446900017 | K093728 | 000 |