Home › DRAEGER MEDICAL SYSTEMS, INC. › Respiratory Mechanics Combined Flow/CO2 Sensor – Pediatric
Respiratory Mechanics Combined Flow/CO2 Sensor – Pediatric
DRAEGER MEDICAL SYSTEMS, INC. · Model 5957142 · UDI-DI 04049098007733
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.