MDOLORIS MEDICAL SYSTEMS

Address:Biocentre Fleming Bat C,Loos Nord,FR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrocardiograph (DPS) (2) Cable, Electrode (IKD) (1) Electrode, Electrocardiograph (DRX) (1)

Premarket Exempt

Yes

Clear

HFVi monitor - 03760232460177 Catalog Number :

Device Description : HFVI Monitor is intended for use in a medical environment and under the direct s HFVI Monitor is intended for use in a medical environment and under the direct supervision of a licensed healthcare practitioner or by personnel specifically trained for its use. The system is intended for use on adult and pediatric patients, in a facility providing patient care by monitoring heart rate variability.The High Frequency Variability Index (HFVI) is a complex monitoring technology intended for use as an adjunct to clinical judgment. Clinical judgment should always be used when interpreting the HFVI in conjunction with other available clinical signs. As with any monitored parameter, artifacts and poor signal quality may lead to inappropriate HFVI values. Potential artifacts may be caused by muscle activity or rigidity, patient motion, improper sensor placement or electrical interference.

Device Class : 2

Duns Number: 262207287

Premarket Exempt : Yes

Product Code : DPS

Prescription Use : Yes

Device Count : 1

BA-HFVI-V1 - 03760232460184 Catalog Number :

Device Description : The acquisiton box BA-HFVI-V1 is to be used with the MDoloris HVFI Monitor (UDI The acquisiton box BA-HFVI-V1 is to be used with the MDoloris HVFI Monitor (UDI number : 03760232460177)

Device Class : 2

Duns Number: 262207287

Premarket Exempt : Yes

Product Code : DPS

Prescription Use : No

Device Count : 1

HFVI SENSOR V1 - 03760232460245 Catalog Number :

Device Description : The HFVI sensor is a disposable, pre-gelled 3-lead array.The HFVI sensor is to b The HFVI sensor is a disposable, pre-gelled 3-lead array.The HFVI sensor is to be usd with the HFVI Pain Monitoring System and may be worn for a continous period of 24 hours in a hospital environment.

Device Class : 2

Duns Number: 262207287

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : No

Device Count : 1

HFVI-SC-V1 - 03760232460283 Catalog Number :

Device Description : The patient cable is used to connect the HFVI Sensor (UDI number 03760232460245) The patient cable is used to connect the HFVI Sensor (UDI number 03760232460245) to the acquisition box BA-HFVI-V1 (UDI number 03760232460184)

Device Class : 2

Duns Number: 262207287

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

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