K241091
- 510(k) number
- K241091
- Device name
- SIMEOX 200 Airway Clearance Device
- Applicant
- Inogen, Inc. CA · US
- Product code
- SDT — Intra-Pulmonary Percussive Vibration (Ipv) Devices
- Decision date
- 2024-12-23
- Date received
- 2024-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241091.pdf
Official FDA record: K241091
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.