Sigmamotor, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Sigmamotor, Inc. makes
Sigmamotor, Inc. manufactures infusion pumps, including modified volumetric infusion pumps and specialized models like the Model 5000 and Cutter 888-00. These devices are designed for controlled delivery of fluids in medical settings, such as intravenous therapy or other infusion applications.
The company’s products fall under FDA Class II devices and are listed via the 510(k) clearance pathway in the United States. The portfolio is regulated under US FDA standards, with devices authorised through the 510(k) process.
Catalogue
Volumet Infusion Pump, Modifi. Of Ref K770849
Regimes: 510(k) Registry: 510(k)Infusion Pump, Model 5000 Ref K782020
Regimes: 510(k) Registry: 510(k)Cutter 888-00 Infusion Pump Ref K782019
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sigmamotor, Inc. have in the registry?
The registry currently lists 3 devices for Sigmamotor, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sigmamotor, Inc.'s devices?
Among its 3 most recently registered devices, Sigmamotor, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Sigmamotor, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sigmamotor, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sigmamotor, Inc. in the registry?
The most recently registered devices listed for Sigmamotor, Inc. include VOLUMET INFUSION PUMP, MODIFI. OF, INFUSION PUMP, MODEL 5000 and CUTTER 888-00 INFUSION PUMP.