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510(k) Data Aggregation

    K Number
    K053156
    Device Name
    MINI-WRIGHT DIGITAL, MODEL 3120001
    Manufacturer
    CLEMENT CLARKE INTL., LTD.
    Date Cleared
    2006-01-31

    (78 days)

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

    CLEMENT CLARKE INTL., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mini-Wright Digital is a handheld, battery operated, electronic Peak Flow Meter and FEV1 monitoring device with an internal memory capable of storing 240 sets of readings. This product will be sold as an OTC device with appropriate instructions. When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed health care professional. The device is intended for use with paediatric and adult patients in both home and clinical settings.
    Device Description
    The Mini-Wright Digital is a handheld, battery operated, electronic Peak Flow Meter and FEV I monitoring device with an internal memory capable of storing 240 sets of readings. This product will be sold as an OTC device with appropriate instructions.
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    K Number
    K042058
    Device Name
    ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
    Manufacturer
    CLEMENT CLARKE INTL., LTD.
    Date Cleared
    2005-03-23

    (236 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEMENT CLARKE INTL., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OneFlow FVC is a handheld, battery operated, electronic Spirometer intended to measure the maximal volume and flow of air that can be moved through a patient's lungs. The device is intended for use with pediatric and adult patients in a variety of clinical settings. Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.
    Device Description
    The OneFlow FVC is a handheld, battery operated, electronic spirometer. Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.
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    K Number
    K000368
    Device Name
    EYECAP IMAGING SYSTEM
    Manufacturer
    CLEMENT CLARKE INTL., LTD.
    Date Cleared
    2000-05-04

    (90 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEMENT CLARKE INTL., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EyeCap Imaging System is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps.
    Device Description
    EyeCap Imaging System
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    K Number
    K982334
    Device Name
    AIRZONE PEAK FLOWMETER
    Manufacturer
    CLEMENT CLARKE INTL., LTD.
    Date Cleared
    1999-01-14

    (196 days)

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

    CLEMENT CLARKE INTL., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AirZone Peak Flowmeter is intended to measure the peak expiratory flow rate for patients who have respiratory conditions such as Asthma, Emphysema or Reversible Airway Obstruction.
    Device Description
    AirZone Peak Flowmeter
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    K Number
    K980960
    Device Name
    IN-CHECK INSPIRATORY FLOWMETER
    Manufacturer
    CLEMENT CLARKE INTL., LTD.
    Date Cleared
    1998-06-10

    (86 days)

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

    CLEMENT CLARKE INTL., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions, and is suitable for use by the Health Care Professional or for home monitoring of nasal or oral inspiratory flow by the patient. Some uses for the device are :- 1. Diagnosis of Nasal Obstruction 2. Assessment of Response to Nasal Provocation 3. Home Monitoring of PNIF 4. Oral Inspiratory Flow Measurement
    Device Description
    The IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions.
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    K Number
    K962074
    Device Name
    VM PLUS PEAK FLOWMETER
    Manufacturer
    CLEMENT CLARKE INTL., LTD.
    Date Cleared
    1997-01-02

    (219 days)

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

    CLEMENT CLARKE INTL., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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