| K-number | K001686 |
| Device name | GALILEO VENTILATOR |
| Applicant | Hamilton Medical, Inc. |
| Product code | CBK |
| Device class | Class II |
| Decision date | Jun 23, 2000 |
| Decision | Substantially Equivalent - Subject to Tracking Reg. |
| Regulation | 868.5895 |
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