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Found 2 results
510(k) Data Aggregation
K Number
K003257Manufacturer
Date Cleared
2000-12-22
(65 days)
Product Code
Regulation Number
862.1345Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Device Name :
EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K002984Manufacturer
Date Cleared
2000-12-18
(84 days)
Product Code
Regulation Number
870.1875Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION
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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