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Found 4 results
510(k) Data Aggregation
K Number
K954730Device Name
BENCHMARK TRANSFER TESTManufacturer
Date Cleared
1997-04-01
(533 days)
Product Code
Regulation Number
868.1880Type
TraditionalPanel
Anesthesiology (AN)Reference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
P.K. MORGAN LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K960121Device Name
AUTOLINK BODY PLETHYSMOGRAPHManufacturer
Date Cleared
1997-01-09
(364 days)
Product Code
Regulation Number
868.1880Type
TraditionalPanel
Anesthesiology (AN)Reference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
P.K. MORGAN 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
K954731Device Name
OXYLOG 2Manufacturer
Date Cleared
1997-01-06
(448 days)
Product Code
Regulation Number
868.1730Type
TraditionalPanel
Anesthesiology (AN)Reference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
P.K. MORGAN 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
K953990Device Name
TRANSFLOW TESTManufacturer
Date Cleared
1996-12-09
(473 days)
Product Code
Regulation Number
868.1880Type
TraditionalPanel
Anesthesiology (AN)Reference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
P.K. MORGAN 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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