| K-number | K152292 |
| Device name | Respire Blue Series-EF |
| Applicant | Respire Medical Holding |
| Product code | LRK |
| Device class | Class II |
| Decision date | Dec 7, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 872.5570 |
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