The technology used in the Meditech ABPM-04, 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.
|Medaval||Legacy approval||Older clinical validation; older protocol|
|BIHS (UK and IRL)||ABPM||Published evidence|
|ESH (Europe)||ABPM||Published evidence|
|Stride BP||ABPM for adults||Published evidence|
|AMA VDL Criteria||Satisfies stated criteria||510(k) K051149 plus BHS:1993 validation|
Barna I, Keszei A, Dunai A. Evaluation of Meditech ABPM-04 ambulatory blood pressure measuring device according to the British Hypertension Society protocol. Blood Press Monit. 1998;3(6):363-8. PMID: 10212378.
BHS:1993 - Pass (B/B) General population
SP10:1992 - Pass General population
Brothwell S, Dutton M, Ferro C, Stringer S, Cockwell P. Optimising the accuracy of blood pressure monitoring in chronic kidney disease: the utility of BpTRU. BMC Nephrol. 2013 Oct 10;14:218. doi: 10.1186/1471-2369-14-218. PMID: 24112304. Available from: PMC3852944.
The publication describes the Meditech ABPM-04 being used as a reference device for comparison with the BPTru-100 & the Dinamap Pro400.