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510(k) Data Aggregation

    K Number
    K051779
    Device Name
    ANDROFLOW - RESPIRATORY RATE MONITOR
    Manufacturer
    ANDROMED, INC.
    Date Cleared
    2005-09-30

    (91 days)

    Product Code
    BZQ
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANDROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Androflo™ is intended for use as an adjunct to patient assessment in continuous monitoring of respiratory rate (breathing frequency). Androflo™ is indicated for clinical use in adult patients under the supervision of qualified health care professionals trained in the use of the equipment. Androflo™ is not intended for home use or for use as an apnea monitor.
    Device Description
    Not Found
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    K Number
    K021389
    Device Name
    BIOLOGICAL SOUND MONITOR (BSM) SENSOR
    Manufacturer
    ANDROMED, INC.
    Date Cleared
    2002-10-01

    (152 days)

    Product Code
    DQD, DOD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANDROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biological Sound Monitor Sensor is intended for the purpose of capturing, detecting and transmitting biological sounds such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The Biological Sound Monitor Sensor may be used with any compatible devices that may amplify biological sound signals for auscultation, display or further processing. The Biological Sound Monitor Sensor is indicated for use with children and adults under the supervision of a physician or other trained health care professional. It is indicated for use during routine exam in clinical or other suitably prescribed environment in conjunction with such devices as an electronic stethoscope. In no way are any of the sensor functions represented as being in and of themselves diagnostic. Sound signals must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.
    Device Description
    Biological Sound Monitor (BSM) Sensor
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    K Number
    K022298
    Device Name
    I-STETHOS LINK
    Manufacturer
    ANDROMED, INC.
    Date Cleared
    2002-10-01

    (77 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANDROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The i-Stethos Link Electronic Stethoscope is intended for the purpose of electronically amplifying and listening to biological sounds, such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The i-Stethos Link may also be used to display the heart rate, which is calculated as the number of heartbeats per minute. In addition, the i-Stethos Link is equipped with an analog I/O port to interface with external devices such as a computer and to accept input from other compatible devices such as the biological sound monitor (BSM) sensor or another i-Stethos Link. The i-Stethos Link Electronic Stethoscope is indicated for use under the same conditions that would otherwise require the use of an acoustic (non-electronic) stethoscope. The i-Stethos Link Electronic Stethoscope is not intended as a substitute for medical care or for diagnosis and treatment by unlicensed or unqualified persons.
    Device Description
    Not Found
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    K Number
    K010729
    Device Name
    AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
    Manufacturer
    ANDROMED, INC.
    Date Cleared
    2001-10-26

    (228 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANDROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001306
    Device Name
    STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
    Manufacturer
    ANDROMED, INC.
    Date Cleared
    2000-07-20

    (86 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANDROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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