Criticare Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 24
What Criticare Systems, Inc. makes
Criticare Systems, Inc. manufactures patient monitoring devices, including pulse oximeters (e.g., 502-US, OSM-1), non-invasive vital signs monitors (e.g., 507), and anesthetic agent monitors. Their portfolio also covers multi-parameter vital signs monitors (e.g., 507EL, 8100/8500, 506CN) with features like arrhythmia detection and ST analysis. Devices track oxygen saturation, respiratory rate, heart rate, and other physiological parameters for clinical use.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. Their products are listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device authorization requirements. The manufacturer operates from the United States.
Catalogue
Search and filter all 24 devicesFrequently asked questions
How many devices does Criticare Systems, Inc. have in the registry?
The registry currently lists 24 devices for Criticare Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Criticare Systems, Inc.'s devices?
Among its 24 most recently registered devices, Criticare Systems, Inc. has devices listed in FDA 510(k) (24 devices).
What risk classes do Criticare Systems, Inc.'s devices fall under?
Among its 24 most recently registered devices, the classes recorded for Criticare Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Criticare Systems, Inc. in the registry?
The most recently registered devices listed for Criticare Systems, Inc. include 507EL VITAL SIGNS MONITOR, ANESTHETIC AGENT MONITOR, MPT 24 AND VITAL VIEW 24 and 8600 VITAL SIGNS MONITOR.