Search Results
Found 3 results
510(k) Data Aggregation
K Number
K963505Manufacturer
Date Cleared
1997-02-14
(164 days)
Product Code
Regulation Number
884.4900Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
TENET MEDICAL ENGINEERING
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
K963506Device Name
TENET RADIOLUCENT HAND TABLEManufacturer
Date Cleared
1997-01-09
(128 days)
Regulation Number
878.4960Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
TENET MEDICAL ENGINEERING
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
K964102Device Name
TENET TIBIAL FRACTURE SUPPORTManufacturer
Date Cleared
1996-12-05
(55 days)
Product Code
Regulation Number
878.4960Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
TENET MEDICAL ENGINEERING
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
Page 1 of 1