Fysicon BV
NetherlandsFDA 510(k) applicant, unverified FDA FEI 3010716438
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Fysicon BV makes
Fysicon BV manufactures hemodynamic monitoring systems, including amplifiers, portable and hybrid monitoring devices, and specialized cardiac output monitoring solutions. The QMAPP series includes standalone and integrated systems for real-time hemodynamic parameter assessment, such as cardiac output and vascular function, primarily for intraoperative and critical care environments.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are subject to FDA oversight. The portfolio is not registered in other major regulatory databases.
Catalogue
- CE MDR 510(k) 510(k)
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) Ref K241766
CE MDR 510(k) 510(k)
Company details
- FDA FEI number
- 3010716438
- Address
- Hoogheuvelstraat 114, Oss Noord-Brabant
Frequently asked questions
How many devices does Fysicon BV have in the registry?
The registry currently lists 2 devices for Fysicon BV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fysicon BV's devices?
Among its 2 most recently registered devices, Fysicon BV has devices listed in FDA 510(k) (2 devices).
What risk classes do Fysicon BV's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Fysicon BV's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fysicon BV in the registry?
The most recently registered devices listed for Fysicon BV include QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP and QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid).