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Welch Allyn ABPM 6100

Device Model:ABPM 6100
Manufacturer:

OBL: Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153, UNITED STATES.

OEM: SunTech Medical Inc., Suite 117, 507 Airport Boulevard, Morrisville, NC 27560-8200, UNITED STATES.

Measuring functions:Blood pressure
Primary Client Use:Intended for ambulatory blood pressure monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Obsolete
Assessment:

While the technology used in the Welch Allyn ABPM 6100, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)ABPMManufacturer declaration of equivalence
ESH (Europe)ABPMThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:Riester ri-cardioB, Suntech Oscar 2B, Welch Allyn ABPM 6100B (B BIHS Derivative)
Validation Publications for Equivalent Devices

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Suntech Oscar 2

Jones SC, Bilous M, Winship S, Finn P, Goodwin J. Validation of the OSCAR 2 oscillometric 24-hour ambulatory blood pressure monitor according to the International Protocol for the validation of blood pressure measuring devices. Blood Press Monit. 2004 Aug;9(4):219-23. PMID: 15311149.

ESH-IP:2002 - Pass General population

Goodwin J, Bilous M, Winship S, Finn P, Jones SC. Validation of the Oscar 2 oscillometric 24-h ambulatory blood pressure monitor according to the British Hypertension Society protocol. Blood Press Monit. 2007 Apr;12(2):113-7. PMID: 17353655.

ESH-IP:2002 - Pass General population