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. Device class: 2.
Clearance details
- Applicant
- Draeger Medical AG & Co. KG
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Telford, PA, US
Recent devices under product code CAH
view allMore clearances from Draeger Medical AG & Co. KG
view allAdverse 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 →
Recalls naming K072002
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072002.
Data sourced from openFDA. This site is unofficial and independent of the FDA.