FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55— 510(k) K072002
Substantially EquivalentDraeger Medical AG & Co. KG
FDA 510(k) clearance K072002 for FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55, Substantially Equivalent on 2008-01-31. Applicant: Draeger Medical AG & Co. KG.
Clearance details
- Applicant
- Draeger Medical AG & Co. KG
- Product code
- Code CAH
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Telford, PA, US
Adverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
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.