Bourns Medical Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 9
What Bourns Medical Systems, Inc. makes
Bourns Medical Systems manufactures respiratory support devices, including flexible ventilation tubing (sizes 9, 20, and 26), patient circuit manifolds, and a range of ventilators for adults and newborns. Their portfolio includes time-cycled ventilators, infant pressure ventilators, and adult volume ventilators, alongside humidifiers designed for use with ventilatory systems.
The company’s devices are regulated under FDA 510(k) clearance and fall into Class I and Class II classifications. Products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
FLEXTUBES:9, 20, 26 Ref K781428
510(k) 510(k)Patient Circuit Manifold Ref K781485
510(k) 510(k)Model Ls-80 Adult Ventilation Monitor Ref K781515
510(k) 510(k)Newbourns Infant Ventilator Ref K802051
510(k) 510(k)Model Bp-200 Infant Pressure Ventilator Ref K801697
510(k) 510(k)Humidifiers, Model:ls-420 And Ls-460 Ref K781760
510(k) 510(k)Ventilator Model BV-300 Infant Ref K790199
510(k) 510(k)Bear 2 Adult Vol. Ventilator Ref K802118
510(k) 510(k)Model Bp-2000 Time-Cycled Ventilator Ref K791186
510(k) 510(k)
Frequently asked questions
How many devices does Bourns Medical Systems, Inc. have in the registry?
The registry currently lists 9 devices for Bourns Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bourns Medical Systems, Inc.'s devices?
Among its 9 most recently registered devices, Bourns Medical Systems, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Bourns Medical Systems, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Bourns Medical Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bourns Medical Systems, Inc. in the registry?
The most recently registered devices listed for Bourns Medical Systems, Inc. include FLEXTUBES:9, 20, 26, PATIENT CIRCUIT MANIFOLD, MODEL LS-80 ADULT VENTILATION MONITOR and NEWBOURNS INFANT VENTILATOR.