BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version

    K Number: K173060 · Decision Jan 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    3
    Review Days
    119

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
    K Number
    K173060
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fisher and Paykel Healthcare Limited
    Date Received
    September 28, 2017
    Decision Date
    January 25, 2018
    Product Code
    CBK
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CBK Ventilator, Continuous, Facility Use

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CBK), ordered by most recent decision date.

    Evita (V800); Evita (V600)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Inbentus Versatile

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VPAP Pediatric Face Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vivo 45 LS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SV600, SV800 Ventilator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Fisher and Paykel Healthcare Limited

    K Number Device Name
    K233829 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)
    K170367 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