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Nihon-Kohden PVM-2700
Device Model:
PVM-2700
Manufacturer:

Distributer: Nihon Kohden UK Ltd., Unit 118 Trident Court, 1 Oakcroft Road Chessington, Surrey KT9 1BD, UNITED KINGDOM.

Other: Nihon Kohden Corporation, 1-31-4 Nishiochiai, Shinjuku-ku, Tokyo 161-8560, JAPAN.

Measuring functions:
Blood pressure, Vital Signs
Primary Client Use:
Intended for patient monitoring
Measurement Site:
Finger
Measurement Occurrence:
Continuous measurement
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Description:
The Nihon-Kohden PVM-2700 is a patient monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the finger. It is intended for bedside patient monitoring.
Assessment:
The technology used in the Nihon-Kohden PVM-2700, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP Japanese Society of Hypertension Professional use (2019-2022) Implied equivalence to the Nihon-Kohden Vismo PVM-2701
Device Family:
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.

Nihon-Kohden Vismo PVM-2701

Alpert BS. Validation of the Nihon Kohden PVM-2701/Impulse-1 automated device by both AAMI (2002) and ISO standards testing. Blood Press Monit. 2012 Oct;17(5):207-9. doi: 10.1097/MBP.0b013e328359c48e. PMID: 22968109.

81060-2:2009 - Pass Adults (n=69) and children (n=41)

SP10:2002 - Pass Adults (n=69) and children (n=41)