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Welch Allyn SureBP Algorithm (Unspecified Device)

Device Name:SureBP Algorithm
Manufacturer:Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153, UNITED STATES.
Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Not made available
Assessment:

The technology used in the Welch Allyn SureBP Algorithm (Unspecified Device), 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; older protocol
ESH (Europe)Professional use for childrenPublished evidence
MDR CriteriaAdultsValidation with amended protocol - may require further study

Validation Publications

Alpert BS. Validation of the Welch Allyn SureBP (inflation) and StepBP (deflation) algorithms by AAMI standard testing and BHS data analysis. Blood Press Monit. 2011 Apr;16(2):96-8. doi: 10.1097/MBP.0b013e328345232f. PMID: 21412074.

SP10:2006 - Pass General population