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510(k) Data Aggregation
K Number
K020270Manufacturer
Date Cleared
2002-03-14
(45 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
Illumination and all body cavities hollow and solid organs
Device Description
Not Found
AI/ML Overview
This document is a marketing authorization letter for the SOPRO 367D Endoscopy Camera. It states that the device is substantially equivalent to legally marketed predicate devices. However, the letter and its enclosures do not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.
Therefore, I cannot provide the requested information based on the provided text. The letter only confirms that the device can be marketed in the US.
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