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510(k) Data Aggregation
K Number
K972301Device Name
BIG BEN SQUARE, BIG BEN ROUNDManufacturer
Date Cleared
1997-09-17
(90 days)
Product Code
Regulation Number
870.1120Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
BIG BEN SQUARE, BIG BEN ROUND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Big Ben Square and Big Ben Round models are sphygmomanomter and are intended to measure the blood pressure.
Device Description
Not Found
AI/ML Overview
This document is an FDA 510(k) clearance letter for a blood pressure measuring device (sphygmomanometer). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device marketed before May 28, 1976, but does not detail performance testing. Therefore, I cannot extract the requested information from this document.
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