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Respiratory Mechanics Combined Flow/CO2 Sensor – Adult/pediatric
DRAEGER MEDICAL SYSTEMS, INC. · Model 5957126 · UDI-DI 04049098007757
10
510(k) clearances
136
Adverse events (2 deaths)
3
Recalls
38
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-01 | Mindray DS USA, Inc. dba Mindray North America | The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification. |
| 2011-07-29 | Respironics Novametrix, LLC. | Pressure lines maybe occluded and display incorrect tidal volumes. |
| 2011-07-29 | Respironics Novametrix, LLC. | Pressure lines maybe occluded and display incorrect tidal volumes. |
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