Nihon-Kohden ZM-940PG
Assessment:
While the technology used in the Nihon-Kohden ZM-940PG, to measure blood pressure, has been claimed as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | Not recommended | This device has not shown to have been clinically validated. | ||
| Japanese Society of Hypertension | Professional use (2016, 2018-2019) | Implied equivalence to the Nihon-Kohden Vismo PVM-2701 | ||
Device Family:Nihon-Kohden BSM-1700J, Nihon-Kohden BSM-3000J, Nihon-Kohden BSM-6000J, Nihon-Kohden CSM-1500J, Nihon-Kohden CSM-1700J, Nihon-Kohden CSM-1900J, Nihon-Kohden GZ-140PJ, Nihon-Kohden PVM-2700J, Nihon-Kohden PVM-9900J, Nihon-Kohden RMC-5000J, Nihon-Kohden SVM-7000J, Nihon-Kohden TEC-5000J, Nihon-Kohden TEC-8000J, Nihon-Kohden ZM-540PGJ, Nihon-Kohden ZM-940PGJ, Nihon-Kohden ZS-640J, Nihon-Kohden ZS-940PGJ (J JHS Implied Equivalence)
