Finapres Medical Systems B.V.

Address:Institutenweg 25,Enschede Overijssel,NL

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Filters

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

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (10) Plethysmograph, Impedance (DSB) (7) Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) (DRT) (1) Oximeter (DQA) (1)

Premarket Exempt

Clear

Finapres - 08719327003701 Catalog Number : FP_907810

Device Description : PP Rechargeable NiMh Battery pack

Device Class : 2

Duns Number: 489470686

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Finapres - 08719327003718 Catalog Number : FP_907805

Device Description : PP Frontend Unit

Device Class : 2

Duns Number: 489470686

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Finapres - 08719327003725 Catalog Number : FP_905803

Device Description : FM Frontend Unit

Device Class : 2

Duns Number: 489470686

Premarket Exempt : No

Product Code : DSB, DXN

Prescription Use : No

Device Count : 1

Finapres - 08719327003732 Catalog Number : FP_902701

Device Description : BeatScope Easy CD + User's Guide

Device Class : 2

Duns Number: 489470686

Premarket Exempt : No

Product Code : DSB, DXN

Prescription Use : No

Device Count : 1

Finapres - 08719327003749 Catalog Number : FP_900702

Device Description : BeatScope 1.1a CD + User's Guide

Device Class : 2

Duns Number: 489470686

Premarket Exempt : No

Product Code : DSB, DXN

Prescription Use : No

Device Count : 1

Finapres - 08719327003756 Catalog Number : FP_910641

Device Description : Nova Scope PC sofware + manual

Device Class : 2

Duns Number: 489470686

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Finapres - 08719327003763 Catalog Number :

Device Description : Valsalva Assembly

Device Class : 2

Duns Number: 489470686

Premarket Exempt : No

Product Code : DXN, DSB

Prescription Use : No

Device Count : 1

Finapres - 08719327003770 Catalog Number : FP_400224

Device Description : Finger cuff size Large NC

Device Class : 2

Duns Number: 489470686

Premarket Exempt : No

Product Code : DXN, DQA, DRT, DSB

Prescription Use : No

Device Count : 1

Finapres - 08719327003787 Catalog Number : FP_400223

Device Description : Finger cuff size Medium NC

Device Class : 2

Duns Number: 489470686

Premarket Exempt : No

Product Code : DXN, DSB

Prescription Use : No

Device Count : 1

Finapres - 08719327003794 Catalog Number : FP_400222

Device Description : Finger cuff size Small NC

Device Class : 2

Duns Number: 489470686

Premarket Exempt : No

Product Code : DXN, DSB

Prescription Use : No

Device Count : 1

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