Mallinckrodt Sensor Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Mallinckrodt Sensor Systems, Inc. makes
Mallinckrodt Sensor Systems, Inc. manufactures pulse oximetry monitoring systems, including the GEM PREMIER PLUS Model 5500 and the GEM-PREMIER System, designed for continuous non-invasive measurement of blood oxygen saturation and pulse rate.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
Gem Premier Plus Model 5500 Ref K961335
Regimes: 510(k) Registry: 510(k)Gem-Premier System Ref K910305
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mallinckrodt Sensor Systems, Inc. have in the registry?
The registry currently lists 2 devices for Mallinckrodt Sensor Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mallinckrodt Sensor Systems, Inc.'s devices?
Among its 2 most recently registered devices, Mallinckrodt Sensor Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Mallinckrodt Sensor Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Mallinckrodt Sensor Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mallinckrodt Sensor Systems, Inc. in the registry?
The most recently registered devices listed for Mallinckrodt Sensor Systems, Inc. include GEM PREMIER PLUS MODEL 5500 and GEM-PREMIER SYSTEM.