510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Finapres Medical Systems B.V.

Enschede Overijssel, NL

FINAPRES MEDICAL SYSTEMS B.V. appears in FDA device records in Enschede Overijssel, NL. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Finapres Medical Systems B.V. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Fms, Finapres Medical Systems BV510(k), enforcement report, recall

510(k) clearance history

FDA records hold 6 510(k) clearances for Finapres Medical Systems B.V. between 2003 and 2018. The busiest year on record is 2003, with 2. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Finapres Medical Systems B.V., by decision year
YearClearances
20032
20071
20151
20171
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K173916Finapres Nova Noninvasive Hemodynamic MonitorDXNSubstantially Equivalent
K160967Finapres Nova Noninvasive Hemodynamic MonitorDXNSubstantially Equivalent
K141460FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITORDXNSubstantially Equivalent
K063111FINOMETER MODEL-2 WITH ACCESSORIESDXNSubstantially Equivalent
K023723FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1DXNSubstantially Equivalent
K023338PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2DXNSubstantially Equivalent

Registered establishments

FDA registered establishments for Finapres Medical Systems B.V., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30038030883003803088FINAPRES MEDICAL SYSTEMS B.V.Institutenweg 25, Enschede Overijssel 7521 PH NL2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2150-2012Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.Battery may become hot and leakClass IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain