K242769
- 510(k) number
- K242769
- Device name
- VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
- Applicant
- Draegerwerk AG & CO Kgaa DE
- Product code
- BTL — Ventilator, Emergency, Powered (Resuscitator)
- Decision date
- 2025-04-04
- Date received
- 2024-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242769.pdf
Official FDA record: K242769
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.