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510(k) Data Aggregation
K Number
K191209Device Name
Aneroid Type Blood Pressure Kit
Manufacturer
Date Cleared
2019-06-18
(43 days)
Product Code
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Mars Medical Products Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. The models MS-200, MS-200M are intended to be manually attached to a patient and manually inflated along with a manual method.
Device Description
Aneroid Type Blood Pressure Kit, models MS-200D and MS-200M are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb.
The proposed device has three models, MS-200/MS-200D/MS-200M. The three models have same intended use, same design and measuring principle, same measuring range and same main components. The only differences among the three models are assembly accessories for fixation and installation of the aneroid sphygmomanometer.
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K Number
K050040Device Name
MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR
Manufacturer
Date Cleared
2005-03-30
(82 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
MARS MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
1. The device is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the Oscillometric method. \ The device also measure pulse rate.
- 2. The device is for adult use only.
- The device is for use at home or while traveling. 3.
Device Description
MS-753 Mars Inflate-Read Blood Pressure Monitor
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K Number
K050039Device Name
MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR
Manufacturer
Date Cleared
2005-03-25
(77 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
MARS MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
1. The device is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the Oscillometric method. The device also measure pulse rate.
2. The device is for adult use only.
3. The device is for use at home or while traveling.
Device Description
Not Found
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K Number
K032825Device Name
VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR
Manufacturer
Date Cleared
2004-12-10
(457 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
MARS MEDICAL PRODUCTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- 1. The device is designed to provide signals from which systolic, diastolic pressures and H-Value (arterial stiffness index) can be derived through the use of the Oscillometric method. The device also measure pulse rate.
- 2. Adult Use Only
- 3. For use in the clinical setting or home use under the direction of a physician.
Device Description
The device is designed to provide signals from which systolic, diastolic pressures and H-Value (arterial stiffness index) can be derived through the use of the Oscillometric method. The device also measure pulse rate.
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K Number
K980845Device Name
MS-900S, MS-900SPM & MS-900SFM
Manufacturer
Date Cleared
1998-12-14
(285 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
MARS MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Blood Pressure Monitors are designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The devices also measure pulse rate.
Device Description
Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Digital Blood Pressure Monitors
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