Search Results
Found 2 results
510(k) Data Aggregation
K Number
K004047Device Name
HOME-AWAY SYSTEM
Manufacturer
IN-X CORP.
Date Cleared
2001-12-18
(354 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
IN-X CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K984570Device Name
MINOLTA PULSOX-3/MINOLTA PULSOX-3I
Manufacturer
IN-X CORP.
Date Cleared
2000-08-30
(616 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
IN-X CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Minolta Pulsox-3 and Pulsox-3i are the devices 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, pulmonary dysfunction or who need sleep study.
Device Description
The Minolta Pulsox-3 and Pulsox-3i are the devices 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, pulmonary dysfunction or who need sleep study. 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.
Ask a Question
Page 1 of 1