BEUDAMED
    FDA Registration Active 🇺🇸 United States

    400470A Forma Full Face Mask

    Reg #: 2085602 · FEI: 3000210616 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FISHER & PAYKEL HEALTHCARE, INC.
    Registration Number
    2085602
    FEI Number
    3000210616
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    17400 Laguna Canyon Road, #300
    City
    IRVINE
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K061236

    Owner / Operator

    Firm Name
    FISHER & PAYKEL HEALTHCARE NZ LTD
    Operator Number
    8040217
    Address
    15 MAURICE PAYKEL PLACE
    City
    EAST TAMAKI, AUCKLAND
    State
    NZ-NOTA
    Postal Code
    2013
    Country
    NZ

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    400470A Forma Full Face Mask 400470SL Forma Full Face Mask 400473SL Forma Full Face Mask 400471SL Forma Full Face Mask HC432 Flexifit Full Face Mask 400471A Forma Full Face Mask 400473A Forma Full Face Mask

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198