Respironics, Inc. · Class II · Cleared Sep 2, 2010
| K-number | K101130 |
| Device name | BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK |
| Applicant | Respironics, Inc. |
| Product code | MNS |
| Device class | Class II |
| Decision date | Sep 2, 2010 |
| Decision | Substantially Equivalent |
| 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