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510(k) Data Aggregation
K Number
K972136Device Name
TV MONITOR (P12/17)Manufacturer
Date Cleared
1997-06-26
(20 days)
Product Code
Regulation Number
892.1600Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Not Found
Device Description
TV Monitor Model P12/17 SCREEN (CRT)
AI/ML Overview
The provided document is a 510(k) clearance letter from the FDA for a TV Monitor Model P12/17. This letter is a regulatory document and does not contain information about acceptance criteria or a study proving device performance against such criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document.
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