Andon BM-091
Assessment:
While the technology used in the Andon BM-091, 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 Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | Not recommended | This device has not been clinically validated. Although equivalence to another device is claimed by the manufacturer, this has not been tested scientifically. | ||
| BIHS | Self-measurement | Manufacturer declaration of equivalence | ||
| ESH | Self-measurement | The BIHS recommendation, despite the absence of scientific evidence according to the same authors' criteria. | ||
Device Family:Andon KD-5031D, Andon KD-556D, Andon KD-557B, Andon KD-558B, Andon KD-5901B, Andon KD-5902B, Andon KD-5905B, Andon KD-5909B, Andon KD-5915B,D, Andon KD-5917B, Andon KD-5918B, Andon KD-595B, Andon KD-5961B, Andon KD-5962B, Andon KD-5913D, Andon KD-5001B, Andon KD-5963D, Andon KD-5971B,D, Beurer BM-44D, Beurer BM-47D, Beurer BM-58D, Beurer BM-65D, Beurer SBM-43D, Desa Pharma Tecnico EasyB, iHealth Track (KN-550BT)B, Medel Check (V1)D, Medel EliteD, Pic Solution Digit SmartD, Pic Solution Digit ExtraD, Salter BPA-9200-GBB, Salter BPA-8200-EUB (B BIHS Derivative, D DET Equivalence)
