BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ANDROFLOW - RESPIRATORY RATE MONITOR

    K Number: K051779 · Decision Sep 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    5
    Review Days
    91

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    Basic Information

    Device Name
    ANDROFLOW - RESPIRATORY RATE MONITOR
    K Number
    K051779
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Andromed, Inc.
    Date Received
    July 1, 2005
    Decision Date
    September 30, 2005
    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 Andromed, Inc.

    K Number Device Name
    K022298 I-STETHOS LINK
    K021389 BIOLOGICAL SOUND MONITOR (BSM) SENSOR
    K010729 AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
    K001306 STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX