Fisher and Paykel Healthcare Limited · Class II · Cleared Aug 23, 2024
| K-number | K233829 |
| Device name | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA) |
| Applicant | Fisher and Paykel Healthcare Limited |
| Product code | BZD |
| Device class | Class II |
| Decision date | Aug 23, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 868.5905 |
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