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510(k) Data Aggregation
Device Name
ALEXANDER MANUFACTURING COMPANYManufacturer
Date Cleared
1997-04-02
(69 days)
Product Code
Regulation Number
880.2910Type
TraditionalPanel
General HospitalAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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Manufacturer
Date Cleared
1997-03-31
(67 days)
Product Code
Regulation Number
886.1570Type
TraditionalPanel
OphthalmicAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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