Computer Dialysis Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Computer Dialysis Systems, Inc. makes
Computer Dialysis Systems, Inc. manufactures automated dialysis systems, including the J.E.T. Dialysis System for renal treatment, and pre-packaged medical-grade sodium chloride solutions (80g and 120g) for intravenous use. The company also produces the COMPUDIAL/KP-1, a programmable dialysis controller for kidney dialysis procedures.
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 the manufacturer is based.
Catalogue
J.E.T. Dialysis System Ref K820575
Regimes: 510(k) Registry: 510(k)Compudial/Kp-1 Ref K813107
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Compudial/Kp-1 Ref K831132
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Computer Dialysis Systems, Inc. have in the registry?
The registry currently lists 4 devices for Computer Dialysis Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Computer Dialysis Systems, Inc.'s devices?
Among its 4 most recently registered devices, Computer Dialysis Systems, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Computer Dialysis Systems, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Computer Dialysis Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Computer Dialysis Systems, Inc. in the registry?
The most recently registered devices listed for Computer Dialysis Systems, Inc. include J.E.T. DIALYSIS SYSTEM, COMPUDIAL/KP-1 and FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G.