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Omron HEM-711

Device Model:HEM-711
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Omron HEM-711, 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
MedavalLegacy approvalOlder clinical validation; older protocol
ESH (Europe)Self-measurementPublished evidence
Stride BPSelf-measurement for adultsPublished evidence
AMA VDL CriteriaSatisfies stated criteria510(k) K052154 plus BHS:1993 validation

Validation Publications

Artigao LM, Llavador JJ, Puras A, López Abril J, Rubio MM, Torres C, Vidal A, Sanchis C, Divisón JA, Naharro F, Caldevilla D, Fuentes G. Evaluación y validación de los monitores Omron Hem 705 CP y Hem 706/711 para automedidas de presión arterial [Evaluation and validation of Omron Hem 705 CP and Hem 706/711 monitors for self-measurement of blood pressure.] Aten Primaria. 2000 Feb 15;25(2):74-84. PMID: 10736939. Available from: www.elsevier.es. In Spanish.

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

SP10:1996 - Pass General population