Nova Micro Pillows Mask Small A Model (NVP1SA) +7 more— 510(k) K233829

Clearance details

Device name as filed

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

Code BZD

Device class

Class 2

Regulation

21 CFR 868.5905

Advisory panel

Anesthesiology

Date received

2023-12-01

Decision date

2024-08-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Auckland, NZ

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Death

4,440

Injury

53,099

Malfunction

213,222

Other

17

Total

270,778

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →