Mallinckrodt Developpement France · Class II · Cleared May 16, 2008
| K-number | K080439 |
| Device name | SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE |
| Applicant | Mallinckrodt Developpement France |
| Product code | BZD |
| Device class | Class II |
| Decision date | May 16, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 868.5905 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov