The following data is part of a premarket notification filed by Grass-telefactor Divison with the FDA for Twin Plus.
| Device ID | K012976 |
| 510k Number | K012976 |
| Device Name: | TWIN PLUS |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | GRASS-TELEFACTOR DIVISON West-warwick, RI 02893 |
| Contact | John B Chatten |
| Correspondent | John B Chatten GRASS-TELEFACTOR DIVISON 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 | 2001-09-05 |
| Decision Date | 2002-02-12 |
| Summary: | summary |