K260604
- 510(k) number
- K260604
- Device name
- BiWaze Clear System
- Applicant
- Abmrc, LLC MN · US
- Product code
- NHJ — Device, Positive Pressure Breathing, Intermittent
- Decision date
- 2026-08-24
- Date received
- 2026-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K260604.pdf
Official FDA record: K260604
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.