FDA.reportPublic FDA data

FYSICON BV

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30107164383010716438FYSICON BV1N2026-01-01Hoogheuvelstraat 114 Oss Noord-Brabant NL 5349BA

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1736581895095009K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI2025-08-27
1736582063907652K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPMWI2017-09-08
1736581360265795

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWI22025-08-27

PMN#