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510(k) Data Aggregation
K Number
K053006Device Name
ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II
Manufacturer
Date Cleared
2006-02-03
(100 days)
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rossmax Digital Sphygmomanometer MANDAUS II is a non-invasive medical device intended to measure the systolic, diastolic blood pressure for adults, using the auscultatory method by detecting Korotkoff sound. This device will be used by trained medical and health care personnel or trained general users.
Device Description
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K Number
K020897Device Name
ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400
Manufacturer
Date Cleared
2002-08-06
(140 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Wrist type non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment.
Device Description
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K Number
K010498Device Name
WRISTWATCH BLOOD PRESSURE MONITOR A46
Manufacturer
Date Cleared
2001-03-20
(27 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K010190Device Name
WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
Manufacturer
Date Cleared
2001-02-08
(17 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ROSSMAX INTERNATIONL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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