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Found 4 results
510(k) Data Aggregation
K Number
K955833Device Name
NIOMED SURGICAL CAPSManufacturer
Date Cleared
1996-03-15
(80 days)
Product Code
Regulation Number
878.4040Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
AMERASIA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K954747Device Name
NIOMED BARRIER GOWNSManufacturer
Date Cleared
1996-03-06
(142 days)
Product Code
Regulation Number
878.4040Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
AMERASIA CORP.
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
K954454Device Name
NIOMED SURGICAL HOODManufacturer
Date Cleared
1996-01-23
(120 days)
Product Code
Regulation Number
878.4040Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
AMERASIA CORP.
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
K954455Device Name
NIOMED BOUFFANT CAPSManufacturer
Date Cleared
1996-01-23
(120 days)
Product Code
Regulation Number
878.4040Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
AMERASIA CORP.
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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