BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    Respiree Cardio- Respiratory Monitor System

    K Number: K250934 · Decision Aug 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    2
    Review Days
    130

    Basic Information

    Device Name
    Respiree Cardio- Respiratory Monitor System
    K Number
    K250934
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Respiree Pte, Ltd.
    Date Received
    March 28, 2025
    Decision Date
    August 5, 2025
    Product Code
    BZQ
    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
    BZQ Monitor, Breathing Frequency

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    Other Clearances by Respiree Pte, Ltd.

    K Number Device Name
    K223681 Respiree Cardio-Respiratory Monitor