VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)— 510(k) K242769
Substantially EquivalentDraegerwerk AG & CO Kgaa
FDA 510(k) clearance K242769 for VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031), Substantially Equivalent on 2025-04-04. Applicant: Draegerwerk AG & CO Kgaa.
Clearance details
- Applicant
- Draegerwerk AG & CO Kgaa
- Product code
- Code BTL
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Luebeck, DE
Adverse events under product code BTL
product code BTL- Death
- 8
- Malfunction
- 3,256
- Other
- 1
- Total
- 3,265
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.