FDA.reportPublic FDA data

MDOLORIS MEDICAL SYSTEMS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30123048363012304836MDOLORIS MEDICAL SYSTEMS1N2020-04-25Biocentre Fleming Bat C 270 rue Salvador Allende Loos Nord FR 59120

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
03760232460177HFVi monitor - 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.+33362092080contact@mdoloris.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1946351219963945K142969ANI MonitorDPS2016-02-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DPS12016-02-23

PMN#

GUDID#

HFVi monitor - 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.

MDOLORIS MEDICAL SYSTEMS

2016-12-21