K233829
- 510(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 NZ
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2024-08-23
- Date received
- 2023-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233829.pdf
Official FDA record: K233829
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.