K243815
- 510(k) number
- K243815
- Device name
- SoClean 3+
- Applicant
- Soclean, Inc. NH · US
- Product code
- QXQ — Respiratory Accessory Microbial Reduction Device.
- Decision date
- 2025-10-10
- Date received
- 2024-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243815.pdf
Official FDA record: K243815
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.