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Found 3 results
510(k) Data Aggregation
K Number
K010389Manufacturer
Date Cleared
2001-03-23
(42 days)
Product Code
Regulation Number
868.5905Type
SpecialPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K003455Manufacturer
Date Cleared
2000-12-06
(29 days)
Product Code
Regulation Number
868.5905Type
SpecialPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K000890Device Name
CHAD THERAPEUTICS OXYMATIC MODEL 401Manufacturer
Date Cleared
2000-06-16
(88 days)
Product Code
Regulation Number
868.5905Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
CHAD THERAPEUTICS OXYMATIC MODEL 401
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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