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

    STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX

    K Number: K001306 · Decision Jul 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    153
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
    K Number
    K001306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Andromed, Inc.
    Date Received
    April 25, 2000
    Decision Date
    July 20, 2000
    Product Code
    DQD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQD Stethoscope, Electronic

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    Other Clearances by Andromed, Inc.

    K Number Device Name
    K051779 ANDROFLOW - RESPIRATORY RATE MONITOR
    K022298 I-STETHOS LINK
    K021389 BIOLOGICAL SOUND MONITOR (BSM) SENSOR
    K010729 AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A