Search Results
Found 2 results
510(k) Data Aggregation
K Number
K972056Device Name
STANDARD ENDOSCOPEManufacturer
Date Cleared
1997-07-30
(58 days)
Product Code
Regulation Number
876.1500Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
LOS is designed for the standard endoscope use in General Surgery, especially for diagnostic in the ENT field.
Device Description
Standard Endoscope
AI/ML Overview
The provided text is a 510(k) premarket notification letter from the FDA for a Standard Endoscope, and does not contain information about acceptance criteria, device performance, ground truth, or study details. It is a regulatory approval document confirming substantial equivalence to a predicate device. Therefore, I cannot extract the requested information from this document.
Ask a Question
Ask a specific question about this device
K Number
K950712Device Name
PORTABLE ENDOSCOPY SYSTEMManufacturer
Date Cleared
1996-05-14
(455 days)
Regulation Number
876.1500Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
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