Bci Intl., Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 20
What Bci Intl., Inc. makes
Bci Intl., Inc. manufactures pulse oximeters, including handheld models and reusable finger sensors, for measuring oxygen saturation and heart rate. Their portfolio also includes capnography devices like the CAPNOCHECK II for monitoring exhaled carbon dioxide levels, as well as non-invasive blood pressure (NIBP) monitors and multi-gas analyzers for respiratory monitoring. Additional products include ECG-capable oximeter/monitors and vital signs monitors for clinical and point-of-care use.
These devices are classified under Class II by the FDA and are authorised through the 510(k) clearance process. The company’s products are listed in the FDA’s 510(k) registry, ensuring compliance with U.S. medical device regulations. Bci Intl., Inc. is based in the United States.
Catalogue
Search and filter all 20 devicesFrequently asked questions
How many devices does Bci Intl., Inc. have in the registry?
The registry currently lists 20 devices for Bci Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bci Intl., Inc.'s devices?
Among its 20 most recently registered devices, Bci Intl., Inc. has devices listed in FDA 510(k) (20 devices).
What risk classes do Bci Intl., Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Bci Intl., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bci Intl., Inc. in the registry?
The most recently registered devices listed for Bci Intl., Inc. include CAPNOCHECK II, MODEL 8400, NEWOX2, AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR and PULSE OXIMETER.