BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    Masimo SafetyNet

    K Number: DEN200011 · Decision Mar 31, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    85
    Review Days
    1136

    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
    Masimo SafetyNet
    K Number
    DEN200011
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    868.2250
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Applicant
    Masimo Corporation
    Date Received
    February 19, 2020
    Decision Date
    March 31, 2023
    Product Code
    QVT
    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
    QVT Monitor For Opioid Induced Impairment Of Oxygenation

    Other Clearances by Masimo Corporation

    K Number Device Name
    K254209 Radius VSM and Accessories
    K243324 Masimo O3 Regional Oximeter
    K250757 Radius VSM and Accessories
    K243305 Masimo W1
    K240229 Masimo W1
    K234021 Masimo Stork
    K214115 MightySat -OTC
    K223721 Masimo Stork
    K232512 Masimo W1
    DEN200076 ORi
    Search all 85 clearances from Masimo Corporation →