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510(k) Data Aggregation
K Number
K053419Device Name
KONICA MINOLTA PULSOX-300, 300I
Manufacturer
KONICA MINOLTA SENSING, INC.
Date Cleared
2006-05-11
(154 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
KONICA MINOLTA SENSING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study.
Device Description
The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemogliobin (SpO2) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study. SpO2 is, as defined in ISO 9919:2005, percent of hemoglobin saturation with oxygen measured by a pulse oximer and displayed as a percentage. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow.
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K Number
K021469Device Name
MINOLTA PULSOX-2
Manufacturer
KONICA MINOLTA SENSING, INC.
Date Cleared
2003-02-12
(281 days)
Product Code
DQA, DOA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
KONICA MINOLTA SENSING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Minolta PULSOX-2 is indicated for the non-invasive monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Minolta PULSOX-2 is intended for use with adult patients. The Minolta PULSOX-2 is for spot-checking only.
Device Description
The Minolta PULSOX-2, is the device for determination of saturation of hemoglobin (SpO2) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease or pulmonary dysfunction. SpO2 is, as defined in 1.3.14 of ISO 9919:1992, percent of hemoglobin saturation with oxygen measured by a pulse oximeter and displayed as a percentage. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow.
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K Number
K010413Device Name
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
Manufacturer
KONICA MINOLTA SENSING, INC.
Date Cleared
2001-08-02
(171 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
KONICA MINOLTA SENSING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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