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Found 3 results
510(k) Data Aggregation
K Number
K970769Device Name
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR
Manufacturer
ARISTO MEDICAL
Date Cleared
1997-08-28
(178 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
ARISTO MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Continuous or spot monitoring of non-invasive arterial oxygen saturation.
Device Description
ComSat Oximeter Sensors / ComSat Pulse Oximeter Probes
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K Number
K961060Device Name
ARISTO ESOPHAGEAL STETHOSCOPE
Manufacturer
ARISTO MEDICAL PRODUCTS, INC.
Date Cleared
1996-06-19
(93 days)
Product Code
BZT
Regulation Number
868.1920Why did this record match?
Applicant Name (Manufacturer) :
ARISTO MEDICAL PRODUCTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960251Device Name
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR
Manufacturer
ARISTO MEDICAL PRODUCTS, INC.
Date Cleared
1996-03-26
(68 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
ARISTO MEDICAL PRODUCTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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