Capnocheck Plus
by Bci Intl., Inc. 510(k)
Active
510(k) K970209
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970209 | Date18 Apr 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1014-2013
In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems.
Specification
- 510(k) Number
- FDA Product Code
- CCK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1400
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Capnocheck Plus is a capnograph that measures respiratory gas CO2 levels, suitable for use as a stand-alone, bedside, or transport device with oximeter option. It combines End Tidal CO2 technology with the flexibility to add pulse oximetry and FiO2 as needed. The device reliably monitors either intubated or non-intubated patients.
The Capnocheck Plus is supplied as a portable monitor and is used in situations where respiratory monitoring is required, such as for mechanically ventilated patients or individuals receiving PCA analgesia. The device has received FDA 510K authorization and is classified under product code CCK.
Other devices from Bci Intl., Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the Capnocheck Plus used for?
The Capnocheck Plus is used to measure respiratory gas CO2 levels in patients, particularly in situations where respiratory monitoring is required, such as for mechanically ventilated patients or individuals receiving PCA analgesia.
Is the Capnocheck Plus portable?
Yes, the Capnocheck Plus is supplied as a portable monitor, making it suitable for use in various settings, including bedside or transport.
Can the Capnocheck Plus be used for both intubated and non-intubated patients?
Yes, the device reliably monitors either intubated or non-intubated patients, providing flexibility in its application.
What additional features can be added to the Capnocheck Plus?
The Capnocheck Plus has the flexibility to add pulse oximetry and FiO2 as needed, in addition to its End Tidal CO2 technology.