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510(k) Data Aggregation
K Number
K962965Device Name
LIGHTSTIC MODEL 360Manufacturer
Date Cleared
1997-01-09
(163 days)
Product Code
Regulation Number
878.4810Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
RARE EARTH MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K962068Device Name
LIGHTSTIC MODEL 180Manufacturer
Date Cleared
1996-11-08
(164 days)
Product Code
Regulation Number
878.4810Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
RARE EARTH MEDICAL, INC.
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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