K252751
- 510(k) number
- K252751
- Device name
- Earflo (EF001)
- Applicant
- Earflo, Inc. CA · US
- Product code
- MJV — Device, Inflation, Middle Ear
- Decision date
- 2026-02-10
- Date received
- 2025-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252751.pdf
Official FDA record: K252751
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.