Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
Similar devices
- 1-Slot CO2 Module w/ kit (Neo) Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- 1-Slot CO2/O2 Module w/ kit (Neo) Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- 115-046935-00 Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- BreathCO VITALOGRAPH (IRELAND) LIMITED
- CO Sensor Module Capnia, INC.
- Carbon Monoxide Breath Sensor CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.
- CoSense ETCO Monitor Capnia, INC.
- CoSense Precision Sampling Set Capnia, INC.
- D-Piece™ BEDFONT SCIENTIFIC LIMITED
- IBP_CO_SidestreamCO2 module(FDA)II Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- IBP_CO_SidestreamCO2 module(FDA/FJ)II Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Jaeger Jaeger Medical GmbH
Select up to two to place side-by-side with this device.