Fukuda Denshi FCL-2000
Device Model:
FCL-2000
Manufacturer:
Fukuda Denshi Co. Ltd., 2-23-5 Kita Ueno, Taito-Ku, Tokyo 110-0014, JAPAN.
Measuring functions:
Blood pressure, SpO2, Temperature, ECG, Respiration
Primary Client Use:
Intended for patient monitoring
Measurement Site:
BP: Upper Arm
Measurement Occurrence:
BP: Intermittent measurements at specified intervals or times
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Description:
The Fukuda Denshi FCL-2000 is a patient monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for bedside patient monitoring.
Assessment:
The technology used in the Fukuda Denshi FCL-2000, 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 Assessment | Recommendation | Basis | |
| 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 (2021-2022) | Implied equivalence to the Fukuda Denshi DS-7000 |
Device Family:
Fukuda Denshi DS-7000J, Fukuda Denshi DS-7200J, Fukuda Denshi DS-8100J, Fukuda Denshi DS-8200J, Fukuda Denshi DS-8500J, Fukuda Denshi DSL-8001J, Fukuda Denshi DS-8007J, Fukuda Denshi DS-8400J, Fukuda Denshi DS-8005J, Fukuda Denshi FCL-2000J
Legend: J JHS Implied Equivalence
Legend: J JHS Implied Equivalence
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.
Fukuda Denshi DS-7000
Alpert BS, Blakely DW. Validation of the Fukuda Denshi DS-7000 patient monitor by AAMI standard testing. Blood Press Monit. 2009 Dec;14(6):274-6. doi: 10.1097/MBP.0b013e328332fd6d. PMID: 19923985.
BHS:1993 - Pass (A/A) In normal mode
BHS:1993 - Pass (A/A) In quick mode
SP10:2002 - Pass Adults and chlidren - In normal mode
SP10:2002 - Pass Adults and chlidren - In quick mode
SP10:2002 - Pass Infants (n=15), Neonates (n=18)