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510(k) Data Aggregation

    K Number
    K091414
    Device Name
    VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH
    Manufacturer
    Date Cleared
    2009-10-21

    (161 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BioCare vTrust 701DH NIBP monitor is a compact, battery-powered monitor which measures noninvasive blood pressure (systolic and mean arterial pressure) and pulse rate based on the principle of plethysmography (oscillometric on inflation). This equipment is intended for use only by qualified medical providers in conjunction with established medical protocols. It is not intended for use in an MRU environment, or in an air transport environment.
    Device Description
    The BioCare vTrust 701DH NIBP monitor is a compact, battery-powered monitor which measures noninvasive blood pressure (systolic, diastolic and mean arterial pressure) and pulse rate based on the principle of plethysmography (oscillometric on inflation). The oscillometric method detects volume displacements within the artery and senses pressure variations within the blood pressure cuff during inflation. The measurement is more quickly and with less patient discomfort than with monitors which measure NIBP during cuff deflation. Cycle time function enables you to pre-set measurement intervals. User can set alarm limits by selectable for high or low range.
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    K Number
    K012829
    Device Name
    STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS
    Manufacturer
    Date Cleared
    2001-11-02

    (71 days)

    Product Code
    Regulation Number
    862.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Stripmax 1210 Urine Chemistry Analyzer is a semi-automatic urinalysis instrument intended for reading UriMate Reagent Strips for Urinalysis. The tests provided on UriMate Reagent Strips are considered routine urinalysis. UriMate Reagent Strips for Urinalysis are dip-and-read test strips intended for use as an in vitro diagnostic aid using urine specimens. UriMate Reagent strips provide qualitative and semiquantitative tests for specific gravity, pH, Blood, leukocytes, nitrite, protein, bilirubin, ketone(acetoacetic acid), glucose, and urobilinogen by visual comparison to a color chart or by use of the Stripmax Urine Chemistry Analyzer. The tests provided are considered routine urinalysis.
    Device Description
    The Stripmax 1210 Urine Chemistry Analyzer is a semi-automatic urinalysis instrument intended for reading UriMate Reagent Strips for Urinalysis. UriMate Reagent Strips for Urinalysis are dip-and-read test strips intended for use as an in vitro diagnostic aid using urine specimens.
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    K Number
    K002855
    Device Name
    BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
    Manufacturer
    Date Cleared
    2000-10-12

    (29 days)

    Product Code
    Regulation Number
    862.1665
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCARE CORP.

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