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Found 16 results
510(k) Data Aggregation
K Number
K060342Device Name
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K
Manufacturer
ROSSMAX INTERNATIONAL LTD.
Date Cleared
2006-04-04
(53 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rossmax Automatic Blood Pressure Monitor, Model MO701k is used to measure systolic, diastolic, and pulse rate for adult individual in a home environment.
Device Description
Not Found
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K Number
K052727Device Name
ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350
Manufacturer
ROSSMAX INTERNATIONAL LTD.
Date Cleared
2005-12-16
(78 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
S380, K350 are non-invasive blood pressure monitors that are used for measuring systolic, diastolic blood pressure and pulse rate. The cuff circumference is 13.5~22cm for adult individual in a home environment.
Device Description
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K Number
K021225Device Name
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
Manufacturer
ROSSMAX INTERNATIONAL LTD.
Date Cleared
2002-05-22
(34 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The blood pressure monitor is used to measure systolic, diastolic, and pulse rates in adult consumers with arm circumference between 22 cm to 32 cm (8.7" to 12.6")
Device Description
Rossmax Automatic Blood Pressure Monitor, model CardioCare 1000i
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K Number
K013539Device Name
ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS
Manufacturer
ROSSMAX INTERNATIONAL LTD.
Date Cleared
2002-01-17
(85 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment.
Device Description
Not Found
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K Number
K013583Device Name
ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS
Manufacturer
ROSSMAX INTERNATIONAL LTD.
Date Cleared
2002-01-17
(79 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment.
Device Description
Not Found
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K Number
K011352Device Name
ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS
Manufacturer
ROSSMAX INTERNATIONAL LTD.
Date Cleared
2001-07-20
(78 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011539Device Name
ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS
Manufacturer
ROSSMAX INTERNATIONAL LTD.
Date Cleared
2001-07-20
(63 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011523Device Name
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138
Manufacturer
ROSSMAX INTERNATIONAL LTD.
Date Cleared
2001-06-14
(28 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993460Device Name
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43
Manufacturer
ROSSMAX INTERNATIONAL LTD.
Date Cleared
2000-01-11
(90 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.
Device Description
Rossmax Automatic Wristwatch Blood Pressure Monitor, model ZA3
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K Number
K993426Device Name
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44
Manufacturer
ROSSMAX INTERNATIONAL LTD.
Date Cleared
2000-01-07
(87 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.
Device Description
Not Found
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