Fisher and Paykel Healthcare Limited · Class II · Cleared Aug 24, 2017
| K-number | K170367 |
| Device name | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small |
| Applicant | Fisher and Paykel Healthcare Limited |
| Product code | MNT |
| Device class | Class II |
| Decision date | Aug 24, 2017 |
| Decision | Substantially Equivalent |
| Regulation | 868.5895 |
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