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SunTech CT40

Device Model:CT40
Manufacturer:SunTech Medical Inc., Suite 117, 507 Airport Boulevard, Morrisville, NC 27560-8200, UNITED STATES.
Measuring functions:Blood pressure, SpO2, Temperature
Primary Client Use:Intended for patient monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Single and repeated measurements
Availability:Available Currently
Assessment:

The technology used in the SunTech CT40, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
BIHS (UK and IRL)Self-measurementPublished evidence
AMA VDL CriteriaGeneral use510(k) K160439 plus 81060-2:2013 and BHS:1993 validations
MDR CriteriaProfessional usePublished evidence

Validation Publications

Polo Friz H, Punzi V, Petri F, Orlandi R, Maggiolini D, Polo Friz M, Primitz L, Vighi G. Simultaneous validation of the SunTech CT40 automated blood pressure measurement device by the 1993 British Hypertension Society protocol and the Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2: 2013 standard. Blood Press Monit. 2017 Oct;22(5):298-301. Epub: 2017 July 31. doi: 10.1097/MBP.0000000000000281. PMID: 28763332.

81060-2:2013 - Pass General population

BHS:1993 - Pass (A/A) General population