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Found 21 results
510(k) Data Aggregation
K Number
K960205Device Name
CPR TRACHEOTOMY CARE TRAYManufacturer
Date Cleared
1996-08-27
(224 days)
Product Code
Regulation Number
868.5800Type
TraditionalPanel
Anesthesiology (AN)Reference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM PACK RELIABILITY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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K Number
K960243Device Name
CPR C-SECTION DELIVERY PACKManufacturer
Date Cleared
1996-05-23
(128 days)
Product Code
Regulation Number
884.4530Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM PACK RELIABILITY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
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AI/ML Overview
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K Number
K960239Device Name
CPR D & C TRAYManufacturer
Date Cleared
1996-05-23
(128 days)
Product Code
Regulation Number
884.1175Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM PACK RELIABILITY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K960216Device Name
CPR SUCTION CATHETER KITManufacturer
Date Cleared
1996-04-15
(90 days)
Product Code
Regulation Number
880.6740Type
TraditionalPanel
Hematology (HO)Reference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM PACK RELIABILITY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K960210Device Name
CPR ORTHO HAND PACKManufacturer
Date Cleared
1996-04-12
(87 days)
Product Code
Regulation Number
880.6850Type
TraditionalPanel
Hematology (HO)Reference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM PACK RELIABILITY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K960213Device Name
CPR TOTAL HIP PACKManufacturer
Date Cleared
1996-04-12
(87 days)
Product Code
Regulation Number
880.6850Type
TraditionalPanel
Hematology (HO)Reference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM PACK RELIABILITY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K960211Device Name
CPR TOTAL KNEE PACKManufacturer
Date Cleared
1996-04-12
(87 days)
Product Code
Regulation Number
880.6850Type
TraditionalPanel
Hematology (HO)Reference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM PACK RELIABILITY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K960206Device Name
CPR DRESSING CHANGE TRAYManufacturer
Date Cleared
1996-04-12
(87 days)
Product Code
Regulation Number
880.6850Type
TraditionalPanel
Hematology (HO)Reference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM PACK RELIABILITY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K960209Device Name
CPR HEART PACKManufacturer
Date Cleared
1996-04-04
(79 days)
Product Code
Regulation Number
878.5010Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM PACK RELIABILITY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
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K Number
K960214Device Name
CPR FOLEY CAHTETER KITManufacturer
Date Cleared
1996-04-01
(76 days)
Product Code
Regulation Number
876.5130Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM PACK RELIABILITY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
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