| K-number | K040011 |
| Device name | POLARIS 2004 CAPNOGRAPH |
| Applicant | Oridion , Ltd. |
| Product code | CCK |
| Device class | Class II |
| Decision date | May 13, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 868.1400 |
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