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Found 3 results
510(k) Data Aggregation
K Number
K010156Device Name
SLEEP PAT 200 DEVICEManufacturer
Date Cleared
2002-06-19
(519 days)
Product Code
Regulation Number
868.2375Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
ITAMAR MEDICAL (C.M.) 1997 LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K010739Device Name
WATCH-PAT 100Manufacturer
Date Cleared
2001-11-06
(239 days)
Product Code
Regulation Number
868.2375Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
ITAMAR MEDICAL (C.M.) 1997 LTD.
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
K Number
K001852Manufacturer
Date Cleared
2001-02-21
(247 days)
Product Code
Regulation Number
870.1425Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
ITAMAR MEDICAL (C.M.) 1997 LTD.
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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