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510(k) Data Aggregation
K Number
K091414Device Name
VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH
Manufacturer
Date Cleared
2009-10-21
(161 days)
Product Code
Regulation Number
870.1130Why 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
K012829Device Name
STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS
Manufacturer
Date Cleared
2001-11-02
(71 days)
Regulation Number
862.2900Why 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
K002855Device Name
BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
Manufacturer
Date Cleared
2000-10-12
(29 days)
Regulation Number
862.1665Why 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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