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Found 3 results
510(k) Data Aggregation
K Number
K970769Manufacturer
Date Cleared
1997-08-28
(178 days)
Product Code
Regulation Number
870.2700Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Continuous or spot monitoring of non-invasive arterial oxygen saturation.
Device Description
ComSat Oximeter Sensors / ComSat Pulse Oximeter Probes
AI/ML Overview
I am sorry, but the provided text is a letter from the FDA concerning the substantial equivalence of the ComSat Oximeter Sensors to a legally marketed predicate device. It does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.
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K Number
K961060Device Name
ARISTO ESOPHAGEAL STETHOSCOPEManufacturer
Date Cleared
1996-06-19
(93 days)
Product Code
Regulation Number
868.1920Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K960251Device Name
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSORManufacturer
Date Cleared
1996-03-26
(68 days)
Product Code
Regulation Number
870.2700Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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