K251326
- 510(k) number
- K251326
- Device name
- Respiration Rate algorithm
- Applicant
- Edwards Lifesciences, LLC CA · US
- Product code
- BZQ — Monitor, Breathing Frequency
- Decision date
- 2026-06-11
- Date received
- 2025-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251326.pdf
Official FDA record: K251326
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.