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510(k) Data Aggregation
K Number
K002543Device Name
COMOACT ULTRASONIC NEBULIZER, MODEL 3060Manufacturer
Date Cleared
2001-06-14
(302 days)
Product Code
Regulation Number
868.5630Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
SAN UP S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K002468Manufacturer
Date Cleared
2001-03-02
(203 days)
Product Code
Regulation Number
868.6250Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
SAN UP S.A.
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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