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. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. 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)