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Bci, Inc.

United StatesFDA applicant, unverified

Devices
13

What Bci, Inc. makes

BCI, Inc. manufactures pulse oximeters, including pediatric and handheld models, as well as oximetry data management software. The company also produces body cavity irrigators, non-invasive blood pressure (NIBP) monitors with integrated pulse oximetry, capnography devices, and large-capacity sharps disposal containers.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records in the FDA’s regulatory database. The company is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

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Frequently asked questions

How many devices does Bci, Inc. have in the registry?

The registry currently lists 13 devices for Bci, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bci, Inc.'s devices?

Among its 13 most recently registered devices, Bci, Inc. has devices listed in FDA 510(k) (13 devices).

What risk classes do Bci, Inc.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Bci, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Bci, Inc. in the registry?

The most recently registered devices listed for Bci, Inc. include BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR, BCI 3180 PULSE OXIMETER, IRRIGATOR, BODY CAVITY and BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER.

Generated automatically from registry data and not verified by a human reviewer.