Fluke Biomedical
Country not established FDA establishment FEI 2921581
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
What Fluke Biomedical makes
Flux Biomedical manufactures medical training and testing devices, including defibrillators with selectable load capabilities, such as the Impulse 7010, and multiparameter patient simulators like the ProSim series. Their product line also covers electrical safety analyzers, such as the ESA615 and ESA620, designed for assessing and verifying medical equipment compliance. Additional offerings include defibrillator simulators, like the Impulse 6000D/7000DP, and a multiparameter simulator, the MPS450, for simulating physiological responses.
These devices are classified under Class II in the US regulatory framework and are listed via the FDA’s 510(k) pathway. The company’s products are intended for use in medical training, equipment testing, and safety verification, adhering to US regulatory standards. Flux Biomedical operates from the United States.
Catalogue
ESA615 Ref K121860
510(k) 510(k)Impulse 7010 Defibrillator Selectable Loads Ref K083347
510(k) 510(k)Prosim 4, Prosim 6, Prosim 8 Ref K110429
510(k) 510(k)Impulse 6000D/7000DP Ref K072114
510(k) 510(k)ESA620 Electrical Safety Analyzer Ref K121722
510(k) 510(k)MPS450 Multiparameter Simulator Ref K103336
510(k) 510(k)
Company details
- FDA FEI number
- 2921581
- Address
- 6920 SEAWAY BLVD., EVERETT, WA, 98203
Frequently asked questions
How many devices does FLUKE BIOMEDICAL have in the registry?
The registry currently lists 6 devices for FLUKE BIOMEDICAL. Devices recorded under merged duplicate company entries are counted once.
Which registries list FLUKE BIOMEDICAL's devices?
Among its 6 most recently registered devices, FLUKE BIOMEDICAL has devices listed in FDA 510(k) (6 devices).
What risk classes do FLUKE BIOMEDICAL's devices fall under?
Among its 6 most recently registered devices, the classes recorded for FLUKE BIOMEDICAL's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from FLUKE BIOMEDICAL in the registry?
The most recently registered devices listed for FLUKE BIOMEDICAL include ESA615, IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS, PROSIM 4, PROSIM 6, PROSIM 8 and IMPULSE 6000D/7000DP.