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510(k) Data Aggregation
K Number
K041778Device Name
REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T
Manufacturer
MAXI-AIDS, INC.
Date Cleared
2004-08-31
(61 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
MAXI-AIDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device measures systolic and diastolic blood pressures and pulse rate. It uses the oscillometric method. It is indicated for use by adults (those 18 years of age and older) at home or in an outpatient setting.
Device Description
The Reizen Talking Blood Pressure Monitor SF860T measures systolic and diastolic blood pressures and pulse rate. It uses the oscillometric method. It is indicated for use by adults (those 18 years of age and older) at home or in another outpatient setting. It has the same technological characteristics as the predicate device.
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K Number
K960567Device Name
HF MEGA EAR
Manufacturer
MAXI-AIDS, INC.
Date Cleared
1996-10-16
(250 days)
Product Code
EPF
Regulation Number
874.3320Why did this record match?
Applicant Name (Manufacturer) :
MAXI-AIDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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