Getinge International, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Getinge International, Inc. makes
Getinge International, Inc. manufactures steam sterilization equipment, including models like the DECOMAT A 8666, and gas sterilization systems such as the DECOMAT 228. These devices are designed for medical facility use to sterilize surgical instruments and reusable medical equipment.
The company’s portfolio is regulated under FDA’s Class II device classification and is listed via the 510(k) clearance process. These sterilization systems are intended for use in the United States.
Catalogue
Steam Sterilization Equipment Ref K821591
Regimes: 510(k) Registry: 510(k)Decomat A 8666 Ref K920413
Regimes: 510(k) Registry: 510(k)Gas Sterilization Equipment Ref K821842
Regimes: 510(k) Registry: 510(k)Decomat 228 Ref K920406
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Getinge International, Inc. have in the registry?
The registry currently lists 4 devices for Getinge International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Getinge International, Inc.'s devices?
Among its 4 most recently registered devices, Getinge International, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Getinge International, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Getinge International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Getinge International, Inc. in the registry?
The most recently registered devices listed for Getinge International, Inc. include STEAM STERILIZATION EQUIPMENT, DECOMAT A 8666, GAS STERILIZATION EQUIPMENT and DECOMAT 228.