Aspen BP-103H
Description: The Aspen BP-103H is a non-clinically-validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Aspen BP-103H to measure blood pressure. However, this device appears to be very similar to another device by the same (OEM) manufacturer. At least one validation needs to be published and equivalence needs to be proven according to protocols compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | Not recommended | This device has not shown to have been clinically validated. | ||
Device Family:Aspen BP-103HZ, Healthcare World BP-103HZ, HyMark DBP-1314 (BP-103H)Z, LotFancy BP-103HZ, Sejoy BP-103Z, Sejoy Joytech DBP-1314 (Sejoy BP-103H)Z (Z Almost Certain)
