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Found 3 results
510(k) Data Aggregation
K Number
K011055Manufacturer
Date Cleared
2001-06-06
(61 days)
Product Code
Regulation Number
876.5130Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GO MEDICAL INDUSTRIES PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K002803Manufacturer
Date Cleared
2000-12-27
(110 days)
Product Code
Regulation Number
876.5130Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GO MEDICAL INDUSTRIES PTY. 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
K000263Device Name
GO MEDICAL BALLOON INFUSION SYSTEMManufacturer
Date Cleared
2000-05-09
(102 days)
Product Code
Regulation Number
880.5725Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GO MEDICAL INDUSTRIES PTY. 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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