The following data is part of a premarket notification filed by Grass-telefactor Product Group with the FDA for H2o.
| Device ID | K974587 |
| 510k Number | K974587 |
| Device Name: | H2O |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | GRASS-TELEFACTOR PRODUCT GROUP 1094 NEW DEHAVEN AVE. West Conshohocken, PA 19428 |
| Contact | James S Bryan |
| Correspondent | James S Bryan GRASS-TELEFACTOR PRODUCT GROUP 1094 NEW DEHAVEN AVE. West Conshohocken, PA 19428 |
| Product Code | OLV |
| Subsequent Product Code | DQA |
| Subsequent Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-09 |
| Decision Date | 1998-03-09 |
| Summary: | summary |