FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO— 510(k) K081447
Substantially EquivalentDraeger Medical AG & Co. KG
FDA 510(k) clearance K081447 for FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO, Substantially Equivalent on 2008-10-08. Applicant: Draeger Medical AG & Co. KG.
Clearance details
- Applicant
- Draeger Medical AG & Co. KG
- Product code
- Code BSZ
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Luebeck, DE
Adverse events under product code BSZ
product code BSZ- Death
- 23
- Injury
- 298
- Malfunction
- 32,987
- Total
- 33,308
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.