BIG BEN SQUARE, BIG BEN ROUND

• K Number: K972301
• Device Name: BIG BEN SQUARE, BIG BEN ROUND
• Manufacturer: RUDOLF RIESTER GMBH & CO. KG
• Date Cleared: 1997-09-17 ( 90 days)
• Product Code: DXQ
• Regulation Number: 870.1120
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

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.

Regulation Number and Section

§ 870.1120 Blood pressure cuff.

(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).