K250860
- 510(k) number
- K250860
- Device name
- BreatheBand® (Model 1000)
- Applicant
- Exemplar Medical, LLC MO · US
- Product code
- BYI — Percussor, Powered-Electric
- Decision date
- 2025-10-02
- Date received
- 2025-03-21
- 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: K250860.pdf
Official FDA record: K250860
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.