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510(k) Data Aggregation

    K Number
    K992618
    Device Name
    RESPALERT
    Date Cleared
    1999-10-29

    (86 days)

    Product Code
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARWILL MEDICAL (PTY) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Harwill Medical RESPALERT is a peak flow monitor that has been-designed to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control. The RESPALERT must be set by a medical doctor or health care worker to a pre-determined measurement using a lung function apparatus at a hospital or clinic. If the patient is unable to produce a whistle when blowing into the RESPALERT, it is an indication that medical treatment is necessary or that it is not effective.
    Device Description
    The Harwill Medical RESPALERT is a peak flow monitor that has been-designed to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control.
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    K Number
    K983202
    Device Name
    HARWILL MEDICAL CERVITULA CERVICAL SPATULA
    Date Cleared
    1999-03-15

    (182 days)

    Product Code
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARWILL MEDICAL (PTY) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Harwill Medical Cervitula is a disposable cervical spatula that is used to collect endo and ectocervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing. The Harwill Medical Cervitula is not intended for use in pregnant women.
    Device Description
    The Harwill Medical Cervitula is a disposable cervical spatula.
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    K Number
    K983204
    Device Name
    HARWILL MEDICAL U-KLIP UMBILICAL CLAMP
    Date Cleared
    1999-02-26

    (165 days)

    Product Code
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARWILL MEDICAL (PTY) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Harwill Medical U-Klip Umbilical Clamp is a device used to compress the umbilical cord.
    Device Description
    Harwill Medical U-Klip Umbilical Clamp
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    K Number
    K980550
    Device Name
    WHISTLE WATCH
    Date Cleared
    1998-08-27

    (196 days)

    Product Code
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARWILL MEDICAL (PTY) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Whistle Watch is a peak flow meter that has been designed to enable asthmatic children to check their respiratory status.
    Device Description
    The Whistle Watch is a peak flow meter
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